title: document no: csvp-um-igmp- csvp 3.000.001 manual … · 2019-02-26 · title: csvp –...

Title:

CSVP – InstantGMP™ User

Manual-3.000.001

Document No: CSVP-UM-IGMP-

3.000.001

Effective upon last signature date

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Approvals

Name Title Organization Signature Date

System Owner:

Richard Soltero

President InstantGMP

6/2/16

Software QA:

Gretchen Rizor

QA InstantGMP

6/1/2016

Version History

Version Date

(MM/DD/YY

YY)

Description of Change

00 02072014 New Document

01/ 2.045 070214 Made changes for the new Unit table/page/workflow.

02/

2.045.008 09/10/14 Updated the new specification workflow.

03/2.045.009 11/17/14 Updated with new batch material use workflow

04/2.050.001 05/18/2015

The default Role can be assigned from the personnel screen.

Personnel may login immediately after role assignment on this

screen. (p 21) Added Optional Features section (p20) Added

note about ability to sort by batch issuance stamp (p89)

Deleted signatures for Material vendor qualification and

updated screen shot. (p 39)

Updated new specification workflow (pp 40-45) Updated

reports to reflect being sourced from within GeneXus. (pp

99-102)

05 /

2.051.002 07/22/2015

Added a section for the new barcode scan features for user

badges and material labels. Added Sign with badge add tests

and browse buttons to icon glossary. Edited Order to sort with

new icon in glossary.

06/

2.052.001 12/2/2015

Deleted CPC, addressed client change, deleted : Selecting “Y”

from the “Qualified Vendor” dropdown will return all

materials that have qualified vendors. “N” will return all

materials whose vendor has not been qualified. “Clear” will

return all materials.”

2.053.002 12/13/2016 project changes, Product name, Primary container, copy

function, version up function, scale up function,

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2.054.002 05/09/2016 Min max patch – new error messages

3.000.001 05/09/2016 See release notes below

Table of Contents

Table of Contents ............................................................................................................................ 2 Release Notes: ................................................................................................................................. 3 User Manual Summary ................................................................................................................. 11 Overview of Main Menu and Sub-menu choices ......................................................................... 11

Abbreviations ................................................................................................................................ 13 Definition Glossary ....................................................................................................................... 15 Icon Glossary ................................................................................................................................ 18

Manufacturing Process Overview ................................................................................................. 24 Starting a New Project .................................................................................................................. 24

Set-Up ........................................................................................................................................... 25 Adding Personnel ...................................................................................................................... 25

Vendors ..................................................................................................................................... 28 Material Types .......................................................................................................................... 30 Material Status .......................................................................................................................... 32

Storage Condition ..................................................................................................................... 34 Unit ........................................................................................................................................... 34

Facility ...................................................................................................................................... 36 Room ......................................................................................................................................... 36 Bin Location.............................................................................................................................. 37 Equipment ................................................................................................................................. 38 Tests .......................................................................................................................................... 39

Methods..................................................................................................................................... 40 Countries ................................................................................................................................... 41

Material ......................................................................................................................................... 43

Material Specifications ................................................................................................................. 46 Creating a Project .......................................................................................................................... 51

Project Definition ...................................................................................................................... 51 Requisitions................................................................................................................................... 59

Inventory ....................................................................................................................................... 62 This module includes Receipt, Status update and Use of a material. ........................................... 62

Material Receipt ........................................................................................................................ 62

Inventory Status ........................................................................................................................ 65 Inventory Management ............................................................................................................. 68 Inventory Location .................................................................................................................... 71 Depleted Inventory.................................................................................................................... 72

Master Batch Records ................................................................................................................... 77

Master Record Cover Page ....................................................................................................... 80 Master Record: Bill of Materials .............................................................................................. 81

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Master Record Equipment ........................................................................................................ 84 Master Records In-Process Tests .............................................................................................. 85 Master Production Record Manufacturing Instructions ............................................................ 86 Master Record: MPR Approvals ............................................................................................... 92

Batch Production Record .............................................................................................................. 94 Batch Production Cover Page ................................................................................................... 95 Batch Record Manufacturing Instructions .............................................................................. 100 Batch Record Approval........................................................................................................... 107

Audit Log .................................................................................................................................... 109

Reports ........................................................................................................................................ 112 Barcode ....................................................................................................................................... 115

_____________________________________________________________________________

Release Notes:

InstantGMP Release Notes for Version 3.000.001 5/9/2016

New User Interface Features in v3.000

• Personalized view on each screen

• Move, resize or hide columns in grids

• Clear Control Preferences Icon clears all view settings on a screen and restores default

view on that screen

• Sort grid data by any column heading

• Collapse and restore menu and search panels

• Set quantity of rows to display for each grid

• Set favorite menu items

• Icons only inside lists; buttons with text everywhere else

• The search and filter functions in a collapsible panel to the right

• Search starts as soon as characters are entered (some delays may be experienced if there

are a lot of records in a grid)

• Page control, "Confirm", "Cancel", "Close" in the bottom panel

• Insert icon replaced by "Add New Record“ button in bottom panel

• Menu in a collapsible panel on the left

• Open folder icon will indicate that the submenus are displayed and a closed folder icon

will indicate that the submenus are hidden.

• Redundant check boxes eliminated

Error messages

• Appear at the top right of the page

• Disappear after a few seconds, but can be recalled by clicking its tab

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Favorites

• Right click on menu item adds title to favorites

• Star icon appears in main header when a favorite is selected

• Clicking star icon shows that specific users' favorites only

• Clicking on “Home" icon at the left side of “Favorites“ shows all menu items

Check mark colors have meanings

• Grey check mark means True (selected), transparent means false

• Yellow check mark means an action is expected

• Green check mark means action is completed

• Red check mark means a problem that stops the workflow

Bin Location Features

• Facility and room specific Storage at each facility identified by Bin location

• Materials in each facility are tracked and managed separately from the inventory at the

other facilities

• Bin Location shown on Inventory summary screens

• History of changes in Bin Location maintained in system

• Bin Location report shows the current inventory in a specified Bin

• Inventory Location is accessed from Inventory Management screen

• To assign/change a material’s location

Select Facility

Select Room

Select Bin where material will be stored

Sign and Confirm

Current Inventory Report

• Now shows bin location of each item in inventory

• Filters show what is in a specific bin location

Other New Features in v3.000

Digits and decimals

All numeric fields now show 6 digits to the right of the decimal

When there are more than 3 digits to the left, commas appear

A single click on the number highlights the entire number and allows it to be replaced

Specifications

When a new version after version 1 is initiated a “Reason for Change” field appears.

New BRP Features

BPR Manufacturing Instructions Summary now in grid format

Status column shows colored icon indicating status of manufacturing step

Yellow check mark means an action is expected

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Green check mark means all actions on that step are completed

Red check mark means a deviation occurred and requires a QA signature

InstantGMP Release notes for version 2.054.001 03/01/16

Improvements

• Automatic conversion of Unit on BPR Instructions to Material Unit.

• Automatic conversion of Unit on BPR Instructions Usage (on multiple lines) to Material

Unit.

Fixes

On some instances when Inventory levels were above 100% the application experience a

printout error.

When a material was added to inventory, the default option was REJECTED instead of

QUARANTINE.

Application was not considering the scenario of using different types of Units in the BPR

Instruction material usage and Target Unit.

Access to Client Option on Administrator menu was not visible for Administrators.

In some instances, when the Production Id was bigger than 40 characters the Inventory

usage on that Batch was not properly shown.

InstantGMP Release Notes for Version 2.053.002 1/6/2015

This version is a patch fix needed for allowing distributors not using units to be able to create

new BPRs from existing approved MPRs.

InstantGMP Release notes for version 2.053.001 12/11/15

New Functionalities

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• New MPR and BPR workflow allows users to navigate between manufacturing

instruction steps without scrolling on summary page.

• New BPR functionality automatically checks for quantity used of material on each step

for defined range.

• Added option to Unlock “Locked” MPRs and make edits. Signature and comment log

retained for that version.

• Introduced Medical Device Manufacturing Industry nomenclature.

• New Min and Max fields to set at the MPR manufacturing instruction steps calling for

use of material part #s.

• Smart fields for Min and Max on the BPR alert user to OOS addition of material.

• New smart messages alert user to inconsistencies in the BOM and the manufacturing

instruction steps with material part # use.

Improvements

• Signature for material use now included on the inventory traceability table in the BPR.

• Inventory Value report now expresses conversion of values based on Cost entered at the

material requisition screen.

Fixes

Some minor spelling errors within error messages.

Filter options on Material Types were not properly displaying results.

Under certain conditions BPR printout showed twice when printing BPRs

Unit for approved inventory shown on Batch issuance error message updated.

InstantGMP Release 2.052.001 12/6/15

New Functionalities

• Expanded badge signature capabilities to system-wide usage.

• Added new workflows focused on Project Management functionalities allowing for

projects to include multiple products for multiple clients with multiple user access control

under multiple roles.

• Added new Material Classifications to help employ naming conventions for incoming

materials versus outgoing manufactured, packaged or labelled WIPs or finished goods.

• Updated the definition of the Product Name which now includes a Material Name,

Strength, Batch Unit and Primary Container and will be displayed as such.

• Added option to “Reject” MPRs.

• Added MPR status definitions for a clearer status control

• In-Process

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• Locked

• Rejected

• Approved

• Added new functionality and Rules for creating MPRs:

• More rules for better Version control and traceability

• More rules and more copy options for better control and traceability

• Option for Automatic Scale up/down of recipe

• Added ability to hide unused or superseded MPRs

• Added sorting for hidden, visible, or all MPRs

• Added new BPR status definitions for clearer processing control

• Generated

• Issued

• In-Process

• Locked

• Reviewed

• Added to Inventory

• Added automated population of Bill of Materials Quantities to be used in BPR

manufacturing instructions.

• Automated population of material use data from the inventory screens to the BPR

instructions with a list of vendor lots and total quantity of material used.

• Added new Inventory Value Report.

Improvements

• Simplified Menu Navigation based on new workflows.

• Improved MPR and BPR printouts.

• Pared down auto filter drop down for authors to only include roles that can write MPR.

• Increased level of detail on Vendor and Material traceability reports.

• Changed Manufacturing date to transition from BPR’s “Issued” to “In-Process” when a

Manufacturing Instruction is open for the first time.

• Simplified change of roles for user with multiple roles.

• Auto-assignment of PM and QM personnel to projects for better visibility and ease of

use.

Fixes

Access to attachments on Approved MPR’s Manufacturing Instructions

Some “Sort” and “Search” functions on main screens not working as expected.

Under certain conditions, if you changed your password and immediately logged out, you

couldn’t login again unless reopening the browser.

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InstantGMP MES Release notes version 2.051.002 6/25/15

New Functionalities

New barcode scanning solution that enhances material handling.

Ability to permanently “hide” and filter Master Records.

New system-wide digital signature scheme implementation through barcode scanning of

validated user badges.

Implementation of Company Logo on login screen along with Company name on

application header for more clarity on customers with multiple instances.

Improvements

Extended Specification Acceptance Limit field to 120 characters long on PDF print out

under Material Specifications

New mechanisms for attachment handling, making them more efficient and user friendly.

Improved company boarding and Material import mechanism.

Lock down of Production # upon QM approval for easier GMP compliance.

New redesign and export functionalities for Quarantine Reports

Improved usability decreasing visibility on non-essential actions.

Fixes

Under certain conditions after session timeout, an immediate login would render the main

menu invisible.

Minor cosmetic fixes on MPR PDF printout.

New Functionalities

New barcode scanning solution that enhances material handling.

Ability to permanently “hide” and filter Master Records.

New system-wide digital signature scheme implementation through barcode scanning of

validated user badges.

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Implementation of Company Logo on login screen along with Company name on

application header for more clarity on customers with multiple instances.

Improvements

Extended Specification Acceptance Limit field to 120 characters long on PDF print out

under Material Specifications

New mechanisms for attachment handling, making them more efficient and user friendly.

Improved company boarding and Material import mechanism.

Lock down of Production # upon QM approval for easier GMP compliance.

New redesign and export functionalities for Quarantine Reports

Improved usability decreasing visibility on non-essential actions.

Fixes

Under certain conditions after session timeout, an immediate login would render the main

menu invisible.

Minor cosmetic fixes on MPR PDF printout.

InstantGMP MES Release notes version 2.050.001 5/26/15

New Functionality:

New streamlined workflow for Material Specifications with less screens and the ability to

filter by “Approved” “Pending Approval” and “All.” *

Option to allow or disallow Finished Goods and WIPs on MPR Bill of Materials.

Ability to assign personnel a default role on the TPersonnel screen.

Ability to sort BPRs by (descending) issuance time date stamp.

Improvements:

Reports are now integrated into IGMP with better functionality and minimal lag time.

QuickBooks Data Transfer Tool official release and improved P.O. report.

Fixes:

Product and Material traceability reports now pull all relevant data.

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Sorting on Material Name on Material screen now works properly

Sorting on Clients on Project screen now works properly.

Attachment names now always present.

InstantGMP MES Release Notes 2.046.002

Additional Functionality:

Data transfer to QuickBooks: Requisitions and Current Inventory

Added Avg Cost/Unit field and Account for Materials – QuickBooks

Report for Cost of Batch ingredients and manufacturing overhead

Added Costing functionality to BOM calculator

Material Types are pre-populated and chosen from a drop down box

Improvements:

Vendor name included on additional screens for easier traceability

Prevents inclusion of part # of FG/WIP in an MPR recipe for said FG/WIP

Requisition screen streamlined

Changes:

Vendors are now Qualified on the Vendor page and there is no need to create vendor groups.

Vendors are now tied to materials at the receipt level

Note: please change any personnel with ADM role meant to sign for PM or QM signatures to

reflect those roles, as the ADM and Site admin roles have recently changed and the ADM has no

signature rights and can only create new personnel. Contact your InstantGMP Support

Associate for screenshots or an Adobe Connect session if you are having difficulty doing so.

Note: IGMP now runs best in Chrome.

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User Manual Summary

This user manual is set up to use Process Flow Diagrams and a training exercise to illustrate

the functions and business rules of the InstantGMP™ MES and the InstantGMP™ VAPE

applications.

The training exercise will lead you through the procedures and data entry steps that will allow for

the production of a batch of encapsulated powder.

InstantGMP MES/VAPE/PRO/INV/MD is a database application designed to manage GMP

manufacturing of any FDA regulated product. It includes entry screens for documenting

personnel information, room activity and equipment histories, project and vendor information,

raw materials and test specifications, purchase orders and inventory tracking as well as Master

Production Records and Batch Production Records.

InstantGMP runs best in Chrome. Please download the free browser:

https://www.google.com/chrome/browser/desktop/index.html

InstantGMP runs on PCs and Macs as well as Windows based tablets (Full version of windows

not RT) and iOS.

Overview of Main Menu and Sub-menu choices

There are eight (8) Main Menu choices that reside at the left of the opening screen. Each of them

have additional sub-menus choices.

The following main menu choices are found to the left of the main application screen. They

contain sub-menu choices which are selected to enter in data. 1. Setup 2. Materials 3. Specifications 4. Requisitions 5. Inventory 6. Logs 7. Project 8. Batch Record 9. Audit 10. Reports

Sub-menus (signified by bold grey text e.g. Set-Up Personnel:) The main menu choices have

sub-menus from which to choose in order to complete various activities. For example, Set-Up

consists of sub-menus that open data tables. The Personnel table contains the names and contact

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information of personnel. The Vendor table contains the names and contact information of

various material vendors.

1. Set Up

a) Personnel

b) Vendor

c) Material Type (raw materials, components, WIP, Finished Goods, etc.)

d) Material Status (Approved, Quarantine, Rejected)

e) Storage Condition

f) Unit

g) Facility

h) Room

i) Bin

j) Equipment

k) Tests

l) Methods

m) Countries

2. Material (including Finished Goods, WIP, and Raw Materials)

3. Specifications

a) Add Material Specifications

b) View Material Specifications

4. Requisitions

5. Inventory

a) Material Receipt

b) Inventory Status (quarantined, approved, etc.)

c) Inventory Management

d) Depleted Inventory

6. Project

a) Project Definition (Project & Product information)

b) WIP/FG material list

c) Project (Client Information)

c) Project Personnel

7. Logs (use, cleaning, maintenance)

a) Room Log

b) Equipment Log

8. Batch Record

a) MPR Record Definition

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b) Batch Production Record

9. Audit

a) Audit Log

b) Audit Attribute

10. Reports

a) Current inventory

b) Inventaory

c) Inventory in Quarantine

d) Equipment CAL/PM Date

e) Production Lot Traceability

f) Vendor Lot Traceability

g) Low Inventory Levels

There is a set workflow inherent to the program so that the GMP checks and balances can be

carried out in real time; thus there is an order in which the training and test scripts must be executed

for success. The order generally follows the menu items from top to bottom.

Your trainer has access to the DBADM (database administrator) dashboard whereby they can

toggle on and off certain features.

Specifications may be turned off (Note: this feature is not meant to be turned on and off repeatedly)

inventory checks for Material amounts can be turned off

Allowance for same user to sign for log and batch record operator and verifier for those not ready

for full adherence to GMPs.

Abbreviations

Abbreviation Description

ADM Administrator (ambiguous role that has access to

personnel screens to get started with the

program)

BOM Bill of Materials

BPR Batch Production Record

CoA Certificate of Analysis

FG Finished Good

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Abbreviation Description

ADM Administrator (ambiguous role that has access to

personnel screens to get started with the

program)

BOM Bill of Materials

ID Identification

IT Information Technology

MPR Master Production Record

MSDS Material Safety Data Sheets

oWIP Outgoing Work In Process

PM Project Manager

PS Production Supervisor

QM Quality Manager

Req Requisition, Purchase Order (with no associated

cost )

WIP Work in Process

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Definition Glossary

Acceptance Limit: result requirement for passing test.

Administrator/ADM: the personnel who have full permissions (except no access to security) set

for MES modules of InstantGMP functions. An Administrator can always view and edit,

however, they are generally not part of manufacturing projects or teams. An Administrator must

be assigned to the system in order to add other personnel and set security.

Approval: Formal permission or sanction needed: signature.

Approved: Confirmed or sanctioned formally, by signature. For materials and products: passed

all specifications and is fit for use, distribution or sale.

Bin Location: location of materials as uniquely defined by further organization than room

#/name.

Batch size: Amount of a finished batch, to be associated with corresponding unit.

BPR: Batch Production Record; the unique and numbered documentation of the manufacture of

a specific production run or batch of product. The BPR will have a unique batch (production or

lot) number and the capture of weights, times, and other results will be specific to one instance of

following the included instructions.

Client: the person or company who is responsible for funding the project.

Close: close the web page without saving changes.

Company: Your firm, plant, or company name (as editable on the DBADM dashboard only; this

is displayed in the upper right hand corner of the application)

Conditional Approval: Confirmed or sanctioned formally, by signature, but with restrictions;

permission to use at risk but not to ship, or pending some specified action.

Confirm: close the web page with changes saved.

DBADM: Data Base Administrator; role in InstantGMP utilized by InstantGMP support

specialist to provide customer service and for QA tester to perform U/FAT/OP/OQ testing.

Formulation ID: number or name identifying the specific recipe, formula, instructions, product

strength, flavor, unit, etc. of a product; Client Product Code can be used as a base.

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Production Supervisor: the personnel role subordinate to Project Manager who is responsible

for overseeing InstantGMP production at the manufacturing site.

Product Code (lite): internal code for product.

In-Process Test: Testing or inspection of any ingredients or components of a product or WIP

during any production phase.

Instance: Customer-specific, secure, cloud-based Database of InstantGMP.

Instance Owner: the company who has been assigned a specific instance of the InstantGMP

data base and who has control of the personnel, materials, facilities, equipment, projects, logs,

specifications, inventory, batch records and security settings for that specific instance.

Insert: to add new record.

Inventory Manager: Role specifically for those who purchase the Inventory version of IGMP

with modified permissions to exclude Projects, masters and batch records and includes more

rights than an operator. (similar to a PM with QM rights for material handling)

Inventory Operator: Role specifically for those who purchase the Inventory version of IGMP

with modified permissions to exclude Projects, masters and batch records and includes more

rights than an operator.

Material: any component, excipient, reagent, active ingredient or drug product that is needed for

or manufactured by InstantGMP.

Material Type: The Physical form of a material.

MPR: Master Production Record, A written template for the recipe and manufacturing

instruction steps and other info necessary for completing manufacture product.

Operator: the personnel who use InstantGMP to perform warehouse and production activities.

Order: drop down which allows users to order the results of a summary screen by any column

header.

Outgoing work in process: Partially processed material that is either held for further

processing, sold to a middleman or distributor, etc. treated like a finished good in inventory

after processing if added to inv via the button on batch record.

Performer: User/operator who completed task.

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Personnel: Interchangeable with user, person assigned a name and password in the application.

Print: provide a hard copy or PDF copy.

Product Name: product to be produced, and for which to write an MPR.

Defined in the project by the concatenation of the material name, strength, primary container and

suffix.

Project: (MES only) precursor to creating an MPR, assigning a WIP or FG part number with

additional titles and associating with a client (differentiate the client/sponsors’ MPRs from other

projects.)

Project Manager: the personnel who have the InstantGMP responsibilities defined in the Project

Initiation SOP. They are generally in charge of the project team and administration for

manufacturing projects.

Production Supervisor: Operations manager at the floor level responsible for Production

Operators and Operations including log responsibilities.

Quality Manager: the personnel who have the InstantGMP responsibilities defined in the

Quality Management SOP. They are generally responsible for quality oversight and approval of

quality operations in manufacturing projects.

Quality Operator: Role allowing for more permissions than an operator for Quality control

analysts.

Quarantine: Isolate or put on hold; not for use until further notice, the status all received and

batch-created materials default to in InstantGMP.

Rejected: Not accepted, not allowed to be used.

Requisition: request/order for materials from vendors.

Save: to retain.

Screen/page name: Developer chosen screen names visible at bottom left of each screen. This

differs from the title of the screen which appears across the top left of each screen in large blue

lettering.

Specification: Set of parameters defining the tests and limits required for acceptance of a

material for use in production or for distribution or sale.

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Status: Standard state of Quality of a component, excipient, API, raw material, WIP or finished

Product; used to assess a material’s safety and conformance to applicable specifications.

Standards are Quarantine, Approved, and Rejected.

System Type: Status of a material, FG, WIP, Raw.

Test: name of the test or goal of a procedure.

Test Method: Description of how a specific test is performed, standard to follow.

Theoretical yield: Amount of product that could theoretically be produced from a recipe in the

MPR given no loss (via deviations, testing/samples, QA inspection rejects, normal operation loss

e.g. lost in air, residue on equipment, batch does not fill full integer of containers, etc.)

Title: User Functional Screen Title visible in Blue font in top left of screen.

Update: to modify a record; add, edit or delete.

User: The individual with a user ID and password.

Verifier: Personnel to sign for verification of a manufacturing step which a performer has

completed.

Verify: to confirm the truth or correctness of (something).

iWIP: Work in process; incoming goods that will be used as ingredients in manufacturing.

Icon Glossary

User Name and Role: A drop down in the upper right hand corner of the screen that lists the

roles that are currently assigned which user may toggle between.

Note: This feature is for convenience and special circumstances and should be used responsibly

and only within the scope of 21CFR part 11.

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Title: At the top of the page the screen name indicates what kind of data the system will display

in the current screen In the example, the title says "MPR Record Definition"

Direct Access Icons: At the upper-right part of the screen there are, depending on user rights,

three active icons:

o Password (change password)

o Favorite

o Home button (resets to see entire menu)

o Security (change user rights to the current screen) , and

o Logout (leave the application)

Pagination Buttons: The information in the grid is displayed in groups of usually 50 records. To

access the next 50, there are paging buttons:

The "First" button: , the "Previous" button: , the "Next" button: and the “Last"

button to access the chosen number of records.

The Qty of rows field allows users to adjust the amount of rows displayed on the screen. Enter

the number desired and select the icon.

In some cases there may be an “Add New Record” button, to add new records.

The Confirm button registers the entered data into the data base. The Close button closes the

screen and returns the user to the previous screen but does not save any changes in the database.

The Search button searches for the entered data. The Clear button clears all data from the search

function and resets the screen to include all data.

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The print button appears on several pages and allows the user to print an MPR or BPR.

A report for Material Specifications can be printed using the report button.

The “Copy Manufacturing Steps From Another MPR” button allows the user to select from a list

of MPRs from which to import the manufacturing steps.

The “Copy Materials From Another MPR” button allows the user to select from a list of MPRs

from which to import the materials.

The “Copy Equipment From Another MPR” button allows the user to select from a list of MPRs

from which to import the equipment.

The “Copy Tests From Another MPR” button allows the user to select from a list of MPRs from

which to import the tests.

The sign button comes in different forms and prompts the pop-up signature box. Performer,

Verifier, PM, QM, Approval signatures are all variants of the “sign” button and are seen

throughout the program.

The Choose File button allows the user to search for documents on his or her computer to attach

to a record. The attachment file Document Name link is available on the records once a file has

been attached. Selecting the hyperlink of the file name will prompt pop-up box for user to choose

what to do with selected file.

The Add Test button adds a line for tests methods and acceptance limits on the specifications

screen.

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The sort/filter selector: In the right collapsible search

panel there will be an option to organize the data on the grid. This drop down box allows

determining how the results will be sorted/filtered

The Show selector is available in the search panel on select

screens and filters for and shows only records that fall under the selected status.

Search /Clear: allows the user to search for records or to clear the current filters. There

are several possible scenarios regarding the use of the filters:

o If the user needs to find a particular record, s/he types the record name and clicks

search.

o If the user does not enter anything at all in the field, then the system will display all

available data, with a default of 50 records per page.

o If the user does not remember the complete record name, s/he can enter any part of it

and the system will search for all records which include the typed string.

o If there is more than one filter and the user enters data in more than one field, the

system will search information that matches ALL filters entered.

The Show drop down: shows only records with status of chosen option

The Data Grid: The area where data is displayed. In each line of the grid there may be

two or three controls:

o A hyperlink, indicated by blue text, which takes the user to the record detail.

o An Update pen Icon ( ) which allows the user to modify the record.

o In some cases there may be a version hyperlink; such as for a material or requisition

which will also be indicated by blue numbers. E.g.: Version: 2.

o The Copy (MPR versioning) icon can be seen on the MPR summary page and

makes a new, editable copy of the closed-out record.

o The version up icon allows user to make a sequentially numbered version of the

chosen MPR and can make changes to certain fields.

o The Scale up icon allows users to scale up the theoretical yield which automatically

scales up the BOM. If the auto populate button is checked, the scaled up amounts are

also transferred to the material action associated with the use of a material on

manufacturing instruction steps.

Note: The min and max are not automatically updated and should be checked.

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o User-selected data lists will include the choice to update or delete an item. The delete

icon will either instantly delete the record to bring up a pop-up screen asking user

to confirm the deletion. Select embedded tables have gray x’s for delete buttons.

o A printer icon to the left of completed records can be selected to print specific

records.

Data Entry “T” Screens

o Some screens will also include a material upload arrow which prompts a selection

list of materials to choose from as a separate pop-up screen. This icon can be seen on

MPR and BPR BOM pages, Project Definition, Manufacturing instruction Step, and

Requisition screens. These screens are data entry screens whose screen names always

begin with “T.”

o Blank checkboxes with dark blue outlines are available on several screens and

indicate that they can be selected; for example:

Note that some boxes (gray with gray checks) are visible from other screens, but they

can only be modified via screens whose names start with “T.” For example, the

HWWMaterialStatus screen shows a list of checkboxes whose statuses can only be

changed on the TMaterialStatus page after selecting the update pen icon.

The attachment file selection button appears on the Material receipt, Material status, MPR and

BPR cover pages as well as the manufacturing instructions of the MPR and BPR; It allows for

the attachment of a word, excel, jpg, or PDF file and is updatable (exceptions to update: after

MPR is locked, after receipt has been signed off and confirmed.) This button will allow the user

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to open existing attachments on material status, material use, material (bin) location, and MPR

and BPR covers.

The calendar icon allows the user to select a date from the calendar rather

than write it out.

Add Material Requisition button allows users to add lines to the requisition grid.

Change Location button allows users to change the location of a material vendor lot # via the bin

location.

The Update button appears on certain pages to allow the user to enter or change data on an

existing record.

The unlock function allows a QM user to unlock a previously locked BPR for the purpose of

adding memos regarding deviation investigations or adding stability data to an attachment.

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The Add Batch Inventory button allows the user to enter the amount of a finished batch produced

so that it can be tracked in inventory.

The Inventory button begins the workflow for a user to allocate use of a material in

real time during batch production via the batch record manufacturing steps or for more general

purposed via the inventory module. Bin location of material can also be accessed.

Manufacturing Process Overview

There are many QA checks and balances written into the program which guide an organized

workflow that follows Good Manufacturing Practices:

Starting a New Project

The checks and balances make quality a built in process that minimizes deviations and

omissions.

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Reference: SOP-101 Project Initiation

Optional features: Some features within InstantGMP are controlled in the background by the DBADM

dashboard. Contact your InstantGMP support specialist to toggle these features on and off:

1. QuickBooks Data Transfer tool 2. Ability to include FG and WIPs as ingredients in a Bill of Materials on the MPR. 3. Scanner Integration 4. Automatic Printing of Label on Receipt 5. Inventory Check Off 6. Specs Off (popular for VAPE) 7. Same person allowed on dual signature (popular for VAPE) 8. Medical Device View vs. MES view

Other optional features: 9. Increase user limit (contact [email protected]) 10. .Data import spreadsheet allows for import of vendor and material definitions (raw,

WIP and FG names) (visit instantgmp.com or contact specialist for excel file with instructions.)

STEP 1. Open your Instance of InstantGMP using your assigned Hyperlink to the secure

web address.

STEP 2. Sign in with your assigned UserID and password or with ADM user ID and

password to create a new user.

(This information is provided by InstantGMP support via email)

Set-Up

Adding Personnel

STEP 3. Navigate to: Set-Up menu Personnel

mailto:[email protected]

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Through this option a user shall have the ability to insert, update and search Personnel. The password

must follow a medium password strength policy.

STEP 4. Select Update pen for ADM.

STEP 5. Enter your e-mail for ADM.

STEP 6. Confirm.

STEP 7. Select Add New Record button to create a new record.

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STEP 8. Enter First and Last Name (Project Manager)

STEP 9. Enter “pass1233” for a medium strength password

STEP 10. Select Project Manager role from the Default Job Function dropdown

STEP 11. The Administrator Rights Permission set is granted by clicking the checkbox

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STEP 12. Click

STEP 13. To add badge information click for the person and select a start date of no

later than current date and an end date of a year from now. (the badge scanner

option must be selected for on the dashboard for the feature to appear)

STEP 14. Repeat these steps for the Quality Manager role

Application Rules:

First Name and Last Name are mandatory.

Only Administrators shall have the authority to grant and revoke the Administration permissions

set. Only Project Managers should be designated as users with AR rights. Project Managers

should not give Administrative rights to any other roles unless the specific person is trained in the

complete application and their project duties include updating administrative information.

Anyone without the Administrator credentials is prevented from making any changes to screens

that are within the Administration menu and its sub-menus.

User ID is automatically assigned by the program with the following formula:

First letter of first name

First seven letters of last name

Sequential number starting with 01. (if Jane Doe were to be added next, she would be

JDoe02)

UserID is not case-sensitive

A password of medium strength is required; (must include alpha and numeric characters.)

Password is case sensitive.

The default Role can be assigned from the personnel screen. Personnel may login immediately

after role assignment on this screen.

After confirmation of the personnel screen, the option to create a badge is available on the

TPersonnel screen and the option to print the badge is available on the HWW screen.

Vendors

STEP 15. Navigate to: Setup Vendor

References: POL-0302 Vendor Selection and Qualification, SOP-212 Program to Qualify Vendors

Users have the ability to insert, update and search for Vendors.

Note: Manufacturer using IMGP must be listed in the vendor table. When FG or WIP materials

are to be produced using InstantGMP Batch records, the vendor list is selected from to identify

the vendor of that manufactured FG or WIP.

Note: The company name entered on the DBADM dashboard will automatically populate as the

first vendor.

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Note: Information other than Company Name is not mandatory and can be filled in at your

leisure

STEP 16. Click

STEP 17. Enter “Training-Great Raw Materials” as a vendor.

STEP 18. Click

Client

STEP 19. Navigate to: Setup Client

Note: A Client is any company ordering/funding projects, and/or represents clientele for whom

your firm does manufacturing, holding, packaging or private labeling.

Alternatively, your firm may be a Client who holds/packages/labels WIP/FG from other

suppliers whom you are mandated by the FDA to procure MPRs and BPRs from in efforts to

trace raw materials to customers and vice versa. There are different ways to set up MPRs

depending on your firm’s role in the process.

Note: The Company added on the Dashboard is automatically auto assigned as the first Client.

STEP 20. Click

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STEP 21. Enter Client Name: Training

STEP 22. Select “United States” from the Country drop down box.

STEP 23. Click

Material Types

STEP 24. Navigate to: Setup Material Types

References: POL-0303 Material Control Requirements, SOP-302 Material Types

Through this option a user shall have the ability to insert, update and search Material Types.

An effective Material Control system is essential to ensure that material and components are procured,

received, approved for use, labeled including expiry date, coded, stored, transported and dispensed

according to documented procedures when InstantGMP™ is used.

Note: These names will be the only items available in drop down boxes when material types need to be

selected and are essential to optimal organization of materials within InstantGMP.

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When new “Material Types” are entered into the system, they must be further classified with a

“System Type.” The three “System types” in the system are Raw Material “RM”, Incoming

Work in Process “iWIP”/Outgoing Work in Progress “oWIP” or Finished Goods “FG” This will

differentiate types of materials in other screens of the application where the system type is not

displayed. This will be important for searches for materials in other data base tables. Only

“Work in Process” or “Finished Goods” material types will appear when a Part # is needed in the

Project Definition screen. Material Types that have a system type of “Work in Process” or

‘Finished Goods” will not be editable. The screen does not have the “update” button available

for these types.

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STEP 25. Click

STEP 26. Enter “Raw Material” in the Material Type Name field

STEP 27. Select “Raw Material” from the Type drop down box

STEP 28. Click

STEP 29. Click

STEP 30. Enter “Packaging” in the Material Type Name field

STEP 31. Select Raw Material from the Type drop down box

STEP 32. Click and repeat steps for the material types that apply to your

operation.

Note: Finished Goods is a preset option and does not need to be entered; however, customization

such as “Encapsulated Finished Goods” can be created for convenience.

Material Status

STEP 33. Navigate to: Setup Material Status

References: POL-0303 Material Control Requirements, SOP-304 Material Status

Through this option a user shall have the ability to insert, update and search Material Status.

Application Rules:

The system will always maintain the material statuses "Quarantine", "Approved" and “Rejected”

which cannot be deleted.

The system will allow entry of other material statuses.

If the “System Status” check box is selected, it locks the “Material Status” name which can then

not be updated, changed or deleted. If the checkbox is not checked, the user can update the

material status at a later time.

Anyone with Administrator rights can check the System Status box and lock in a custom name

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and Status indicator (Quarantine/Approved.) This ensures that should a custom status be created,

it will always be identified to a root Status; e.g. “QA retains; Quarantine” or “Ready for Shipping;

Approved.”

Note: “Is Quarantine” is used as a default to define the status when an incoming material is first

received or internally produced WIP of FG is logged into the inventory after production.

A Material Status of “Is Quarantine” prevents the material from being used in a production batch.

Only the material types in this screen will appear in drop down boxes for material approvals.

Optional: steps 29 – 36, adding customized Material Statuses.

STEP 34. Click

STEP 35. Enter “FG Retains/Stability” in the Material Status field

STEP 36. Select the “Is Quarantine” checkbox

STEP 37. Click

STEP 38. Click

STEP 39. Enter “Approved for R/D” in the Status field

STEP 40. Check the box for “Is Approved”

STEP 41. Click

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Storage Condition

STEP 42. Navigate to: Setup Storage Condition

Reference: SOP-412 Environmental Chambers and Storage

Note: “Storage Conditions” refer to the conditions that are available in the facility covered by an

instance of the data base. Only the storage conditions in this screen will appear in drop down boxes

when storage conditions have to be specified.

Through this option a user has the ability to insert, update and search Storage Conditions.

If there are stability chambers, cold rooms and warehouses, each condition should be entered.

The Storage Condition Name is a unique and required field.

STEP 43. Click for the “Ambient” selection.

STEP 44. If your facility has specifications for ambient room temperature such as: 18 C

45%RH, or 68-73 F, 44% RH, enter it here. If not, make no changes.

STEP 45. Click

Unit

STEP 46. Navigate to: Setup Unit

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“Unit” refers to units of measure that will be used in the purchasing of materials and in creating batch

formulas. The unit conversion feature enables the operators to purchase material in larger quantities (e.g.:

kg) and deplete the inventory in smaller quantities (e.g.: g).

Application Rules:

Only the units in this screen will appear in drop down boxes when units have to be specified.

Additional static units may be added by selecting the insert button and confirming a new

entry. These units will not be interchangeable nor will they convert from or to any other

unit.

The Unit Name is a unique and required field. (this only applies to additionally added units, which

for most companies is not necessary.)

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Facility

STEP 47. Navigate to: Setup Facility

Reference: SOP-404.01 Facility Start-Up and Shut-Down, SOP-401.01 Performance

Qualification of Systems (PQ), SOP-402.01 Facility Access and Security, SOP-403.01

Warehouse and Production Area Cleaning and Maintenance.

“Facility” refers to the buildings/Campuses where manufacturing/holding/packaging is to be

tracked in a single instance of InstantGMP software system. Through this option a user has the

ability to insert, update and search Facilities.

System Rules:

Only the facilities entered on this screen will appear in drop down boxes for specifying

facilities.

The Facility Name is a unique field.

STEP 48. Click

STEP 49. Enter Facility name “Training-Manufacturing Site”

STEP 50. Click

Room

STEP 51. Navigate to: Setup Room

References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and

Facility, SOP-406.01 Equipment and Room Logs and Status Tagging

Through this option a user shall have the ability to insert, edit and search Rooms.

Room refers to any numbered room or designated space used for storage/holding, processing or

packaging of materials and components, as well as any spaces used to support or facilitate those

functions or processes documented in InstantGMP. (e.g. weigh room, airlock, gowning room,

controlled hallways, etc.)

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Application Rules:

Only the rooms entered via this screen will appear in drop down boxes when rooms have

to be specified.

Every Room must be linked to a Facility. This is implemented via mandatory selection of

a Facility from a drop-down box to define a room.

Room number must be unique per facility. Room names can be used multiple times.

STEP 52. Click

STEP 53. Select “Training-Manufacturing Site” from the Facility drop down box.

STEP 54. Enter the room number 99900 and room name Z -Training

STEP 55. Click

Bin Location

STEP 56. Navigate to: Setup Bin Location

References: SOP: 420 Facility Maintenance and Modifications

Application Rules: Facility must be unique and is required.

STEP 57. Click

STEP 58. Select “Training-Manufacturing Site” from the Facility drop down box.

STEP 59. Select “99900-Z -Training”

STEP 60. Enter “102” for Bin Number

STEP 61. Enter “Samples” for Bin Location

STEP 62. Click

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Equipment

STEP 63. Navigate to: Setup Equipment

References: POL-0304 Equipment Management, SOP-400 Qualification of Equipment and Facility, SOP-

406.01 Equipment and Room Logs and Status Tagging

Through this option a user has the ability to insert, edit and search Equipment. The Equipment Code is a

unique field entered by the user.

Application Rules:

Only the equipment in this list will appear in drop down boxes when equipment has to be specified.

Equipment name and number are mandatory

STEP 64. Click

STEP 65. Enter in Equipment Number “999999” and Equipment Name “Training - Equip”

(required fields.) Add arbitrary numbers to model and serial number. Select

calendar and current date for due dates.

STEP 66. Click

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Tests

STEP 67. Navigate to: Setup Tests

Reference: SOP-215.00 Tests

“Tests” are the titles of the attributes, quantitative or qualitative, that will be used to determine whether

materials in question are in compliance with specifications. A Test names what is being tested for.

Application Rules:

Through this option a user shall have the ability to insert, update and search Tests.

Only the tests entered in this screen will appear in drop down boxes when tests have to be specified.

The Test Name is a unique field.

STEP 68. Click

STEP 69. Enter “Micro”

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STEP 70. Click

STEP 71. Repeat steps for more tests if applicable to your operation

Methods

STEP 72. Navigate to: Setup Methods

Reference: SOP-216.00 Methods

Application Rules:

“Methods” are the actual procedures that will be used when testing of materials is

required to show the materials are in compliance with specifications. A method is How to

test.

Through this option a user shall have the ability to insert, update and search Methods.

Only the methods confirmed via this screen will appear in drop down boxes when

methods have to be specified

The Method Name is a unique field.

STEP 73. Click

STEP 74. Enter Method associated with a test. “USP (62)” Note: a specific SOP #, procedure

#, or Assay name could be used here as well.

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STEP 75. Click

STEP 76. Repeat steps for more Methods that are applicable to your operation

Countries

STEP 77. Navigate to: Setup Countries

“Countries” identify locations where manufacturing/holding/packaging/labeling facilities are

located or where personnel are based.

Application Rules:

Only the countries in this screen will appear in drop down boxes when countries have to

be specified.

Through this option a user shall have the ability to insert, update and search Countries.

The Country Name is a unique and required field.

STEP 78. Click

STEP 79. Enter Country name. “UK”

STEP 80. Click

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Material

STEP 81. Navigate to: Materials

References: S308 Part # Assignment and POL-0208 Project Initiation

Through this option a user has the ability to insert, update, and search Materials.

“Materials” are parts and components for manufacturing or the products of manufacturing.

Material Classifications separate these two types of materials for ease and organization:

Incoming raw materials, components, packaging and labelling and incoming WIPs

Vs.

Outgoing WIPs and finished Goods (in house WIP counts as outgoing since it is manufactured

Note: The components, excipients, raw materials, incoming and outgoing work in processes and

finished goods WIPs are materials that are either ordered for further use in production,

precursors to products to be manufactured in-house or shipped to be further processed elsewhere.

Example: bulk powder herbal blends are FG for the blend manufacturer but are Raw Material for

the encapsulator. For the encapsulator, bulk capsules are WIP if packaging is done in-house or

FG if sent to a third party.

Application Rules:

Materials should only be ordered from approved/qualified vendors; see business rules on

Vendor Qualification.

Note: InstantGMP and applicable SOPs assume that all materials ordered are from

qualified vendors according to SOP-0212 – Program to Qualify Vendors.

The Part Number is a read-only and auto-numbered field assigned by the application

Material Name is a unique field. An error message will be displayed if a duplicate is

entered.

Products to be manufactured are automatically assigned Part #’s by the system prior to

production so these materials can be tracked by the system prior to and after

manufacturing.

Material Classification, Material Name, Type, Unit and Storage Condition are required

fields.

The Material Name will be a read only field after it is created.

In the Material Update screen shown below, the Material name cannot be edited.

Vendor number is akin to a catalogue number from a vendor; individual lot numbers are

entered later.

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The application will alert user with red error messages when any mandatory field has

been overlooked.

The selected Unit for outgoing materials should represent the Material units

required when creating the batch.

o Note: Take time to consider ordering unit, densities used in any calculations and

unit of sale item. This is a crucial step of the organizational process that can save

you consulting hours in the long run.

The search panel on the right includes a search for part #, material name, material ID and a filter

for Material type.

STEP 82. Click

STEP 83. Select “Raw Material/In-Coming WIP/Other” Material Classification

STEP 84. Click

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STEP 85. (Mandatory) Select the (Material Type) “Ingredient-RM” (See Figure 21)

STEP 86. (Mandatory) Enter the Material Name “Training-Raw Powder”

STEP 87. (Mandatory) Select the unit of measure associated with the material. “g”

STEP 88. Enter the Material ID “Training Raw 1”

STEP 89. Enter the Material Description “Fine white powder”

STEP 90. (Mandatory) Select Storage conditions from the dropdown box. “Ambient”

STEP 91. Enter a shelf life (based on stability studies, the limiting ingredients’ expiration date

or a default standard) “12 months”

STEP 92. Enter QM retest period (based on QA retain or stability test specifications) “12.000”

STEP 93. Enter a vendor order number if known (static number used from a supplier to

represent that material): “TrainingGRM-1”

STEP 94. Select Vendor from the dropdown box. “Training-Great Raw Materials” (Select

your own company for products produced or packaged in-house)

STEP 95. Click

STEP 96. Repeat steps 81 through 91 for “Training-Capsules” (See Figure 21)

STEP 97. Repeat steps 81 through 91 for “Training-Container” (See Figure 21)

STEP 98. Repeat steps 81 through 91 for “Finished Encapsulated Product FG” (See Figure

21)

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Note: For this material’s Select Material Classification Use “Finished Good/Outgoing WIP”

Material Type Ingredient-RM Component-RM Primary

Container-RM

Packaged/Labeled-

FG

Material Name Training-Raw

Powder

Training-

Capsules

Training-

Container

Finished

Encapsulated

Product FG

Unit g ea ea kg

Material ID Training Raw 1 Training Raw 2 Training PC Training Finish

Material

Description Fine white powder Clear, no band

vegetarian gel

White plastic

bottle

Encapsulated

Powder

Storage

Condition Ambient Ambient Ambient Ambient

Recommended

Shelf Life 12 months 12 months 120 months 12 months

QM Retest

Period 12 3 12 3

Vendor Order

Number TrainingGRM-1 TrainingGRM-2 TrainingHDPE

Vendor Training Great

Raw Materials Training Great

Raw Materials

Training Great

Raw Materials

Figure 21

Note: Confirmation will return user to the HWWMaterial screen with a summary of all materials

confirmed.

Material Specifications

Specifications for Raw materials including any components, labels, etc. or incoming WIPs may

be any tests completed to prove the purity, strength, identity or general physical properties and

fitness for use in production. This also includes any visual comparison to a known standard as

well as other organoleptic methods.

Specifications for outgoing WIPs and FGs produced in-house may also have specifications for

final purity and strength, retain and stability testing and in-process testing such as fill volumes or

weights of capsules, pH, uniformity of color or viscosity, inspection of containers, closures,

packaging and labelling, among others.

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STEP 99. Navigate to: Specification

The Material Specifications page “HWWSpecification” screen shows all specifications, allowing

for filtering for “Approved,” “Pending Approval” and “All.”

Application Rules:

The record is automatically assigned a sequential version number.

A user has the capability to insert, update and delete tests/methods/etc. for a Material

Specification until both the PM and the QA signatures are confirmed. No further changes

can be made after the PM and QM approvals are confirmed.

Part #s with an update icon indicate that the material specifications have not yet been

approved and locked.

A version 2 cannot be created until the version 1 signatures have been confirmed.

(A part # whose specification is open (not locked) will not appear on the “Select Part # to

version Up” screen (and a new specification version cannot be created) because the prior

version has not yet been approved and is still editable.) Open records will only appear on

the HWWMaterialspecification screen and can be seen by filtering for “pending

approval” or “ALL”

QM and PM approval is necessary for the Material to be used in the Bill of Materials of

an MPR, inventory, or projects.

If a material needs different specifications for different uses (e.g. lactose in a liquid

product vs. lactose in a powder product), a new material part number must be created and

assigned unique specifications.

Different versions of a material specification may be used concurrently in different MPRs

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This list is comprised of materials with specifications still pending one or more signatures and

materials for which specifications are completed and locked down.

Note: if you expected to see records on this screen but do not, select filter in the right collapsible

panel, for “ALL” to display those records.

STEP 100. Click to create new specification.

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This list is comprised of new materials without specs assigned and materials with signed off specs

for which a new specification record can be generated. If a material does not appear on this list, the

material has an open record that needs to be edited and/or signed. To access open records, select

the “Cancel” button to return to the hub screen and filter for “Pending Approval” or “All.”

Records with update arrows can be modified and signed and locked.

STEP 101. To create version 1, Click the for the “Training-Raw Powder” Material.

Note: Even if no data is entered, confirming creation of this record will move the record to the

HWWSpecifications screen for in process records awaiting approval.

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STEP 102. Enter the effective date or current date of the test specifications for the material.

STEP 103. Enter the MSDS/ Safety and Handling Data “Wear gloves and mask; handle and

store in cool dry environment”

STEP 104. Enter General Sampling instructions for the material “Use plastic scoop #3 to

aliquot 5 grams into each of three plastic sample jars. Secure lid and label”

STEP 105. Click Add test button

STEP 106. Select test “Micro” from drop down.

STEP 107. Select Method “USP <62>” from drop down.

STEP 108. Enter a Acceptance limit of “<0 CFU”

STEP 109. Enter a Sampling of “In Process Visual”

STEP 110. Select the box for Required for Release

Note: The box for release indicates that the test in question is required to meet specs before the material

or product is released for R&D, production use, distribution or sale.

STEP 111. Click

STEP 112. Log out

STEP 113. Login as PManager01

STEP 114. Select Signature prompt for Project Manager/Project Supervisor

STEP 115. Click

STEP 116. Log out

STEP 117. Log in as QManager01

STEP 118. Select Signature prompt for Quality Manager

STEP 119. Click

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STEP 120. Repeat steps for the remaining material part #s in order to set and approve

specifications for all materials needed for production including the finished good product:

Material Name Training - Capsules Training-Container Finished Encapsulated

Product FG

Effective Date Use current date Use current date Use current date

Safety/Handling Don gloves, keep cool

and dry

Don gloves, keep cool

and dry

Don gloves, keep cool

and dry

Sample Instructions Clean dry scoop/Close

and label with lot#,

personnel initials and

date/see methods.

Clean dry scoop/Close



date/see methods.

Clean dry scoop/Close



date/see methods.

tests Select a test and method

from drop down

Select a test and method

from drop down

Select a test and

method from drop

down

STEP 121.

Note: A New sequential version (2) may be created by clicking the hyperlink for part number on

the version up screen and repeating steps for a part number with an approved specification

version 1. Reason for change is required.

Creating a Project

Application Rules:

Your firm should be entered as a Client as well as a Vendor; this may be accomplished in

one step by having your support specialist (the DBADM) enter your company into the

“Company” field on the DataBaseADMinistrator dashboard.

Project Definition

STEP 122. Navigate to: Project

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STEP 123. Click

Application Rules:

The Project Title is a unique and required field.

The Project Title is read only once the Project is created.

Only parts that are “oWIP” or “Finished Goods” can be selected in the Part Number field.

Multiple part numbers may be selected for a single project.

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Multiple products built on the same part number are allowed per project

STEP 124. Enter the Project Title “Training -Finished Encapsulated Product”

STEP 125. Enter a Project description (optional)

STEP 126. Select WIP/FG Part # Tab

STEP 127. Click

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STEP 128. Click for “Training - Finished Encapsulated Product FG”

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STEP 129. Enter Strength

STEP 130. Click for the Primary Container part # selection list

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STEP 131. Select the hyperlink for the Primary container

STEP 132. Enter a Product Name Suffix (optional)

STEP 133. Click

STEP 134. Select the Client tab

STEP 135. Add secondary client if applicable

STEP 136. Select the Personnel tab

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Note: Delete personnel from the project or add personnel to the project using

button

STEP 137. Click to add a secondary role for the PM

Application Rules:

Each person must be assigned a Job Function in order to log into the application. (Until a

primary role is assigned on the TPersonnel screen,, the application has no permission

boundaries set for that person; the default is no permission set and the person cannot get

to the main menu) See Personnel page for other options.

Personnel can be assigned different roles for different projects.

Personnel can be assigned multiple roles per project.

A person can be an MPR Approver and/or a BPR Approver, or neither.

Each Project should have at least one MPR and at least one BPR approver assigned.

STEP 138. Click

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STEP 139. Select Quality Manager role from the drop down

STEP 140. Click

STEP 141. Select update icon for PManager01

STEP 142. Select the MPR and BPR checkboxes

STEP 143. Click

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Requisitions

STEP 144. Navigate to: Requisitions

Through this option a user can create a material requisition with multiple materials from the

same vendor.

Application Rules:

The system will allow a user to build a requisition using materials from a single vendor.

One and only one vendor is identified per requisition.

Only approved Material Specification versions will appear in selection list

The Part Number, Unit, and Qty fields are required fields for each line of the requisition.

Unit chosen must be equivalent to or convertible to the unit assigned to part # on Material

page

Amounts ordered for a material requisition can be converted to other units within that

unit system but cannot be converted from weight to volume or vice versa.

The system will assign a unique requisition number for each requisition created.

Once a Requisition is signed and confirmed it cannot be edited. The system will display a

print icon yielding a PDF version of the requisition

No update icon will be displayed when the record is no longer editable.

STEP 145. Click

STEP 146. Select the Vendor “Training-Great Raw Materials”

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STEP 147. Select needed by date (Today’s date)

STEP 148. Click

The Select Material Specification pop up will appear

STEP 149. Select “Training - Raw Powder” (popup is closed automatically

STEP 150. Enter Qty “3.010”

STEP 151. Select the unit kg from the unit drop down box.

If not already present, Enter “TrainingGRM-1” in the Vendor Order Number field.

STEP 152. Make sure to check the boxes for MSDS and COA. (Material Safety Data Sheets

and Certificate of Analysis)

STEP 153. Click

Repeat steps 142 through 147 for Vegetarian Capsules as seen below:

STEP 154. Click at the bottom of the page

STEP 155. Enter credentials and confirm.

STEP 156. Click

Vendor Material Name Unit Quantity Vendor Part

Training Great

Raw Materials

Training Raw

Powder

kg 3.010 Training-

GRM-1

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Training Great

Raw Materials

Training

Capsules -

Vegetarian

ea 1000 Training -

GRM-2

Training Great

Raw Materials

Primary

container

ea 100 TrainingHDPE

STEP 157. Select the printer icon on the requisition screen.

STEP 158. Print and or email electronic copy of the Requisition Order to Project Manager.

(Functionality will depend on version of Adobe)

Regardless of the accompanying software, the printout will appear as below:

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Inventory

This module includes Receipt, Status update and Use of a material.

Material Receipt

STEP 159. Navigate to: Inventory Material Receipt

Application Rules:

For each line (Part #/Material) of a requisition order, the system shall create a unique

Receipt Number for each material received per requisition which is auto-numbered and

read-only. This number is created at the time of requisition confirmation.

A digital signature is required to save a material receipt record.

The system will allow a user to record the receipt of a specified quantity of material,

which is added to the inventory upon confirmation of signature.

The system will allow a user to search for a material based on either Part Number,

Receipt Number, requisition number or material name.

The system will allow a user to record inventory usage details for each receipt number in

the system.

Through this option a user can search all the material that was ordered and ready to be

received as well as any partial records awaiting signature confirmation.

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STEP 160. Click for a part number to receive

STEP 161. Select the MSDS and COA checkboxes indicating that the data was received.

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STEP 162. Enter the Qty received 3.010

STEP 163. Select the unit received

STEP 164. Enter Vendor lot # “Training 2,” representing the specific lot received.

STEP 165. Select calendar icon and select today’s date for date received.

STEP 166. Select calendar icon for “Use by” date; select one year from now by selecting double

arrow icon and selecting date.

STEP 167. Attach any COAs or MSDSs via the “Choose File” buttons.

STEP 168. Click

STEP 169. Enter credentials

STEP 170. Click

STEP 171. Repeat steps for the remaining part number receipt Vegetarian Capsules.

Vegetarian Capsules Primary Container

Qty Rcv 1000 100

Units ea ea

Vendor Lot Number Training-GRM 2 TrainingHDPE

Date Received Use current date Use current date

Use By One year from current

date

One year from current

date

Application Rules:

Qty received, date received and vendor lot number are required fields

Upon confirmation of a material receipt record, that receipt# is no longer available on the

receipt screen

Upon confirmation of a material receipt, the record becomes available in the Material

Status section with a default status of “Quarantine” and on the Material use screen.

Inventory Status

STEP 172. Navigate to: Inventory Inventory Status

Application Rules:

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Only a Quality Manager (or inventory manager in the INV system) can change the status

of received inventory.

Any updates require a digital signature and will always display the UserID/time/date

stamp from the latest confirmed update.

The default value for all materials is Quarantine.

The Inventory Status screenshot shows the record created for a material received.

STEP 173. Select the Receipt number hyperlink

STEP 174. Logout and log back in as a QM OR toggle to the QM role in the upper right hand

corner of the application.

STEP 175. Click

STEP 176. Expand the Status drop down box and select Approved

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STEP 177. You will be redirect to a page to enter credentials and confirm

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STEP 178. Write “Training- All tests passed, see attachment” in the comment field

STEP 179. Select the browse button and attach a document to represent test results.

Note: the hyperlinked file names can be selected to bring up an open/save window for the previously

attached document.

STEP 180. Click

STEP 181. Repeat steps for Vegetarian Capsules and Primary Container.

Inventory Management

STEP 182. Navigate to: Inventory Inventory Management

Application Rules

Once a material is received in Material Receipt, the received quantity is populated in the

Quantity Rcv field expressed in units from receipt screen.

Qty remain will be expressed in units from the Tmaterial screen

A record will be created for each Material received in Material Receipt

A quantity greater than zero must be entered..

A user shall have the capability to remove/deduct (edit) material amount from each

Material Receipt Line with Quantity available.

The system will display the history of inventory usage records and the inventory balance

for each receipt number.

The system will allow a user to enter an inventory usage record using convertible units

(i.e.: g/mg; mL/L) and properly record the inventory balance in the default unit for that

receipt.The Project Manager will need to reconcile the inventory manually if multiple

sub-shipments of a material with the same lot number are received in the same day. If a

material is received on a single receipt with multiple sub-lots with different lot numbers

(split lots), then the Project Manager will have to create another requisition and a

subsequent receipt for each of the sub-lots.

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STEP 183. Select the receipt number hyperlink for a part number.

STEP 184. Click

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STEP 185. Enter “1.0” in the Quantity Used field

STEP 186. Select “g” from the Unit drop down box

STEP 187. Enter “Training Exercise- Testing” in the Purpose box

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STEP 188. Click

STEP 189. Enter credentials and confirm

Optional: Select gray attachment button or attach another document.

STEP 190. Click

Inventory Location

Inventory Location allows users to assign and change the location of an entire material receipt’s

vendor lot#/material/amount/unit via the bin location tied to a facility and room.

STEP 191. Click receipt hyperlink for material

STEP 192. Click

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STEP 193. Select the Facility, Room and Bin Location from the drop downs

STEP 194. Sign and Confirm

Depleted Inventory

STEP 195. Navigate to: Inventory Depleted Inventory

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Application Rules

Materials with a 0 balance will be in this list.

The page is Read Only.

Through this option a user can view, order and search all the Material Receipt lines with

no Quantity available.

STEP 196. Navigate to: Logs Room Log

Through this option a user shall have the ability to insert, update and view the log entries of the

Rooms and Equipment defined on the corresponding Administration screens.

Note: The room name can be a number.

STEP 197. Select Room # hyperlink for Facility

STEP 198. Click Enter:

Facility Training - Manufacturing Site Room Name Z - Training Activity Room Cleaning Cleaning Agent, Lot # Alcohol solution, Lot #222 Prod Name or Part # n/a Batch n/a Temperature 18 C Relative Humidity 45% Comments Room cleaned according to SOP CLN-002

Note: Temperature and humidity are only relevant if the room is supposed to be controlled.

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STEP 199. Select Operator Sign button, enter credentials and confirm.

STEP 200. Sign in as a QM

STEP 201. Select Review signature button, enter credentials and confirm.

STEP 202. Click

STEP 203. Navigate to: Logs Equipment Log

Equipment Log screen:

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Note: Start Date, End Date, Cleaning Agent, Product Name or Part # and batch refer to the

previous batch run in the equipment unless the cleaning is a periodic cleaning or not associated

with a batch. This is controlled by your facility’s SOPs.

Note: Equipment numbering convention to consider: YYY-XXX where YYY is the alphabetic

acronym for the equipment and XXX is the sequential number of that type of equipment for that

specific item.

STEP 204. Select Hyperlink for Equipment number

STEP 205. Click

STEP 206. Enter data as shown below:

Equipment Number a Equipment x Activity Calibration Start Date/Time Use current date and time End Date/Time Add 4 hours to above Cleaning Agent, Lot # n/a Prod Name or Part # n/a Batch n/a Comments Equipment calibrated according to Equipment SOP

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STEP 207. Have an Operator and Project Manager each sign for the activity.

STEP 208. Click

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Master Batch Records

STEP 209. Navigate to: Batch Record -Master Production Record

Through this option a user can add, edit, view, search, sort and hide, copy, version up, scale up

and print Master Production Records or Master Device Records.

To use the new Hide function, select the checkbox for those records you want hidden and confirm. To see

those records, select “Hidden” from the search Status drop down as search. To see only active records

select “Active.” “All” displays all records.

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Application Rules:

Project Title, Product name, Client, Author, Formulation ID, and Theoretical Batch Yield

and Unit are mandatory

The Product Name is tied to the project title and is a concatenation of Product name,

strength, primary container and suffix.

Bill of Materials, Equipment, In-Process tests, and manufacturing instructions are all

editable via the MPR tabs until a record is locked down

is used to edit a record

is used to delete a record

Approvers are assigned responsibility of approving MPR records via checkboxes on the

Project Personnel page and must sign for an MPR in order to create Batch Records from

the MPR.

Approvers can be edited via the Project Personnel Tab under projects

Upon confirmation of first assigned MPR approvers’ signature for MPR approval, the

record is locked down

Another required approver may unlock an MPR to make edits, at which point the first

signatory must sign again for the new changes.

Note: if only one signatory is assigned, the first approval locks the record for good.

Only one signature for reject will reject and lock the batch

A new version and/or a copy of the rejected batch may be created

An MPR, including attachments, will be read-only once all assigned MPR Approvers

approve the record.

Each MPR can have multiple versions.

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MPR versioning is controlled by signatures and a version button ; a version must

have the same Project title, product name, formulation ID, Theoretical Batch size,

strength (if applicable) primary container (if applicable) and BOM list amounts and units.

A Copy of an MPR must begin with a change in one or more of the following fields:

project title, product name, client, formulation ID, and Theoretical Batch yield.

Once an MPR or version copy has been created, it cannot be deleted but may be hidden.

In order to use the scale up functionality , the MPR used as a template must have had

the “Auto populate BOM Qty on Mfg. instructions” checkbox checked.

The “Auto populate BOM Qty on Mfg. instructions” checkbox can only be used to auto

populate the BOM quantities on the manufacturing instruction “Actions” when each

material in the BOM is used in the batch and the entire amount/unit Qty designated on the

BOM is used in one step.

Note: according to the FDA, An MPR is a Master template for Batch Records; a batch

record must be created for each and every time the recipe/instructions detailed in the

MPR are followed for batch production.

The scale up feature will scale up/adjust the material amounts on the BOM

The scale up feature will scale up/adjust the material amounts on the Manufacturing

instructions but NOT the min and max values, as the system does not assume that

doubling the amount would double the parameters.

Theoretical Batch yield is a read-only display of the theoretical yield as shown on the

cover page. This will be updated when the scale up calculator is used.

Users have the capability to select materials to be used.

For each chosen material, a unit must be chosen.

Changes can be made until MPR is approved and locked or rejected.

The “Quantity Required” refers to the amount of each part# that will be staged for

production. This can include components, filters, bottles, capsules, caps, packaging

labels, etc.

“Composition” refers to the amount of material that will be within a set unit of the final

product when manufacturing is completed. (e.g. mg/mL, mg/capsule, g/serving, etc.)

Copy materials from another MPR button allows user to select MPR from which to copy

all materials amounts and units.

Delete all button deletes all records on that screen including those not copied from

another MPR.

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Master Record Cover Page

STEP 210. Click

STEP 211. Select Project Title: “Training-Finished Encapsulated Product” from dropdown

menu.

Note: Version will auto-populate upon confirmation of page.

STEP 212. Enter the following information:

Project name* Training-Finished Encapsulated Product

Product Name* Finished Encapsulated Product FG-

Client* NEW

Author* Project Manager

Formulation ID* Dry Run Product Strength** 14 Theoretical batch

yield*

1002

Batch Size 1000 BPR Unit * kg Primary Container**

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Amount/Primary

Container

Primary Container

Amount Unit g

# of Containers 10

Purpose Training Supplement, Digestive health Scope Dry Run Attachment select “Browse” button and select an excel, word, PDF or jpeg file

* required

** populated with product name if identified during product name

STEP 213. Click

Master Record: Bill of Materials

STEP 214. Navigate to: Materials (Bill of Materials Tab)

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STEP 215. Click

STEP 216. Click to select a material

STEP 217. Select part # hyperlink for “Training-Raw Powder” for version 1 from list

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STEP 218. Enter data from table below into fields:

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STEP 219. Click

STEP 220. Repeat steps for Vegetarian Capsules, Primary Container

Material/Part#

Training

Raw

Material

Training

Vegetarian

Capsules

Primary

Container

Quantity

Required 3 1000 100

Unit kg ea ea Composition 3 1 3 Comp. Unit g ea ea

The Copy Manufacturing Instructions button allows users to copy BOM materials amounts and

units from selected MPR.

Master Record Equipment

STEP 221. Navigate to: Master Production Record Equipment

Application Rules:

Users have the capability to add delete and copy equipment to be used.

Changes can be made until the MPR is approved or rejected.

STEP 222. Click

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STEP 223. Select x(a) from drop down box

STEP 224. Click

STEP 225. Optional: repeat for Scale or other equipment entered from drop down

Master Records In-Process Tests

STEP 226. Navigate to Master Production Record In Process Tests

Note: these steps may alternatively be integrated into the manufacturing instruction

steps.

STEP 227.

Application Rules:

Users have the capability to add, copy and delete in-process tests that must be performed

during batch production.

Test and Method fields are required fields.

Changes can be made until MPR is approved.

STEP 228. Click

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STEP 229. Enter 1.00 for test number

STEP 230. Select “Micro” from the Tests drop down

STEP 231. Select “USP (62)” from the Method drop down

STEP 232. Enter “Check for defects” in the Test Purpose field

STEP 233. Enter “<5% failure per batch” in the Test Specification field

STEP 234. Click

Master Production Record Manufacturing Instructions

STEP 235. Navigate to: Master Production Record Manufacturing Instructions

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Definitions for Manufacturing Instruction Screens:

Step Number: numerical identification manually assigned to a manufacturing instruction

so that the system can sequentially order the instruction steps.

Part # upload arrow: If a component or material is to be used for completion of a step, it

can be added by using the prompt arrow to display the Part # selection screen

Version #: the version number of the required Part # has to be selected to assure the

material with the proper specifications is used.

Inventory: If a material is to be used in this step, select the “Inventory” check box. This

will alert the operator during batch manufacturing to enter the amount of material that is

used at that step and this will decrement the amount from inventory in real time.

Performer: If a signature of the activity performer is required at this step, select the

check box.

Verifier: If a signature of a verifier is required at this step, select the check box

Material Action: shows action as “Measure (amount/unit/) of (material name)” (smart

field updated with scale up if auto pop check is selected)

Action: the instructions for operators to follow in order to complete the step

Range: If an activity requires a measurement, then a range of acceptable values can be

entered.

Target: (smart field updated with scale up if auto pop check is selected) an activity

requires a measurement, then a target value can be entered.

Min: (smart field) numerical entry for the minimum allowable Qty for step with material.

(associated with Unit)

Max: (smart field) numerical entry for the maximum allowable Qty for step with

material. (associated with Unit)

Unit: Unit of measure tied to the Target and Range, Min and Max.

Attachment: word, excel, PDF, jpeg file attachment e.g. SOPs, device spec drawings,

spreadsheet formulas, forms, links to videos, COAs for material lot used, workflow

diagrams, pictures of machinery, etc.

Application Rules for MPR Manufacturing Instructions:

MPR Version is a read-only field.

Steps will be sequentially ordered (ascending)

Part number upload arrow displays a material selection list based on the MPRs Bill of

Materials.

If Performer and Verifier checkboxes are checked in the MPR manufacturing step, then

those same boxes will automatically populate in the BPR, prompting mandatory digital

signatures.

If the inventory checkbox is checked in the MPR manufacturing step, then that same box

will automatically populate in the BPR, allowing the user to deplete an amount in

inventory Associated with that step.

If the Auto populate BOM QTY on Mfg. Instructions is checked on an MPR cover,

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o The BOM amounts and associated units will populate actions on the instruction

steps.

o The approvals tab will display error messages when material part #s included on

the BOM are not included in a manufacturing instruction step.

o The approvals tab will display error messages when material part #s included on

the manufacturing instruction step(s) are not included BOM.

o The approval tab will display error messages for any materials in the BOM that

were identified in more than none manufacturing instruction step.

o The MPR manufacturing instruction steps will display error messages if the target

defined in the BOM is not within range of the min and max entries.

Data that is not confirmed will be lost. Always confirm data in fields before navigating

via hyperlink or button to other functions.

STEP 236. Click

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STEP 237. Enter “PREP” in the Action field

STEP 238. Select the “---” for the Unit dropdown

STEP 239. Click (Step will be labeled “0”)

STEP 240. Click

STEP 241. Enter data as below:

Step 10

Unit “---”

Action “Check room log for

cleaning of prep room

according to SOP-CLN-

xxx”

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STEP 242. Click

STEP 243. Click

STEP 244. Enter 20 for the step number

Note: it is best to leave numerical leeway between steps for possible additions during editing or

in later versions of the MPR

STEP 245. Select the upload arrow

STEP 246. Select “Training-Raw Powder” from the Selection list (version # auto-

populates)

STEP 247. Select checkboxes for Inventory, Performer and Verifier

Note: If the Auto populate Qty on BOM to Mfg. instructions was chosen on the cover page, an

action will appear automatically instructing the operator to “Measure out Qty/unit of material

part#”

STEP 248. Enter data as shown:

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Action Tare scale.

Record Scale Equip # and Calibration date.

Min .99

Max 1.2

Target 1.0

Range .99-1.2

Unit kg

STEP 249. Click

For Training purposes two steps are sufficient; however, if more practice is needed, one can

certainly use the examples below to create multiple steps and signature sets. Bear in mind that

each of the signature boxes checked must be signed for at the batch record level.

Manufacturing steps to consider for a GMP MPR include:

Counting and verifying labels – expiration date, product name, country of origin, dosage

or recommended scope, any mandated info (e.g. for dietary supplements signifying

product is a Dietary Supplement; not intended to cure treat or prevent disease; not

endorsed by FDA)

Checking Cleaning room logs,

Checking equipment cleaning logs and calibration dates

Obtaining line clearance from QC (environmental testing) or operators (debris and last-

batch labels cleared away/cleaning)

Staging materials (checking statuses, writing lot numbers and expiration dates, moving to

weigh station, cleaning, prepping utensils and bags/bowls)

Calibrating, tare weights, calibration dates of Scales/ recording

Turning on filters, air controls, water skids, machinery

Individual steps for operators to follow in order to run any of the machinery

o Time to do so

o Speed/level/

Gowning/Donning PPE safety equipment – gloves, respirator, booties, hairnets etc.

Weighing – actual weights recorded, each ingredient needs 2 signatures (controlled step)

Mixing- methods and tools

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Recording times of holding, mixing, heating,

Recording environmental factors; temp, humidity

Reconciliation of bottles, caps, labels, as well as FG/WIP samples/retains, rejects

In-Process Testing-

o visual uniformity checks; blended powder, dissolved solution

o pH, viscosity,

o Micro, Chem or other test samples set aside, etc.

o QA inspection of capsules/bottles/seals/label placement,

o Average weights of capsules/fill volumes, etc.

o Packaging instructions, from label to pallet

Note: for each step; decide what the risk to consumer safety or business reputation is for that

action not being completed correctly and mandate performer and verifier signatures

accordingly. Controlled steps such as exact weights or times or those requiring calculations

should always be checked for both signatures to be compliant with FDA regulations.

Master Record: MPR Approvals

Navigate to: Master Production Record MPR Approvals

MPR Approver names and associated roles with the options to sign for approve or reject are

displayed.

Note: Error messages specific to steps and or material part #s will appear for authors and

approvers to see before attempting to sign. These errors pertaining to inventory use must be

resolved before an MPR can be approved.

STEP 250. Select the Sign button for approve

STEP 251. Sign with credentials and confirm

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STEP 252. (log out and log in as another signatory) Sign with the unlock button to

unlock the record; write in a reason for unlocking the record in order to

proceed.

STEP 253. Make a change to one of the manufacturing instructions or add or delete an

instruction.

Note: Signature for first approval and first signature for unlock are logged and

the Approve and Reject buttons are available to all signatories.

Application Rules for MPR Approvals:

Users that have been identified as “MPR Approver” via checkbox on the Project

Personnel screen will populate the MPR Approval screen. (Note: this defaults to none; all

the PMs and QMs in the system for each new project are assigned )

Once one approval signature is confirmed, the entire MPR record is locked but can be

unlocked by a second required signatory and the record can be updated. A reason for

unlocking the record is required.

Note: if only one signatory is assigned to a project, an MPR for that project will be

permanently locked upon first approval.

Any new updates create a new version which will copy the current version except the for

approval actions.

MPR must be approved before it can be issued/viewed/executed as a BPR.

All information previously entered into the MPR (except Approvers) shall be visible and

locked/un-editable to ensure each time a batch is made it is made using the exact same set

of instructions.

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Batch Production Record

STEP 254. Navigate to Batch Record Batch Production Record

Application Rules for Batch Records:

Through this option a user can add, edit, view, search, issue, perform, approve and print

BPR Records.

Batch records can be printed before, during and/or after completion of the record.

A Batch can only be created from an approved MPR (exception: Approval signatures) to

ensure that each time a batch is produced it is made using the exact same set of

instructions.

The system will assign a unique batch number to each BPR record.

Users may add in a legacy number for their batch records in the production # field

Cover Page, Materials, Equipment, In Process Testing and Manufacturing Instruction

tabs shall show all the information that was locked down in the corresponding MPR.

Cover Page, Materials, Equipment, In Process Testing tabs shall be read-only

All tabs are locked until the Issuance button is signed by QA

Issuance button prompts the application to check whether the materials in the

BOM/formula/recipe are*:

o in an approved state

o with signed off specifications

o from a qualified vendor (currently assumed by ordering process)

o available in sufficient amounts

Once the Batch has been issued, the Manufacturing Instruction tab allows for the entry of

step results in real time during manufacturing by operators

Once any required data is confirmed the status of the batch goes from issued to in-process

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Users that have been identified as “BPR Approver” on the Project Personnel page will

populate the Executed BPR Approvals screen.

The system will allow a user to create multiple Batch Production Record (BPR) copies

from an approved MPR.

*Exceptions are for those opting to toggle off specifications and/or inventory checks.

Batch Production Cover Page

STEP 255. Navigate to: Batch Record BPR Cover Page

Show drop downs allow user to see only records of a certain status:

Generated: A batch that has been created but not issued

Issued: A batch that has been issued but does not have a manufacturing date

In-Process: A batch wherein any data has been confirmed on any step

Locked: A batch that has one approval signature confirmed. (no subsequent unlocking)

Reviewed: A record with all required approval signatures

Added to Inv: A batch that has been added to inventory via the BPR cover page.

Users may show Hidden, Visible, or both hidden and visible records (all).

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STEP 256. Click

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STEP 257. Select “Training-Finished Encapsulated Product” from the Project Title

drop down box

STEP 258. Select “Training-Finished Encapsulated Product-FG-14-Primary Container”

from the Product name dropdown box

The form is auto-filled with information from the MPR.

STEP 259. Enter “Training Exercise” in the Production # field

STEP 260. Click

STEP 261. Click

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STEP 262. Toggle to or sign in with a QA role

STEP 263. Click enter credentials and confirm

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STEP 264. Click

Note: Production number is now locked down upon Batch Issuance via QM signature. This is to

protect traceability.

Certain items of the batch record are now editable using on the BPR Cover page

Note: Users may sort batch records by double clicking on the desired column name.

STEP 265. Select the Materials tab to view the Bill of Materials (read-only)

STEP 266. Select the Equipment tab (read-only)

STEP 267. Select the In-Process Tests tab (read-only)

The Cover Page also allows for attaching documentation and printing the

Batch Production Record.

Note: the cover page attachment approved in the MPR can be overridden at the BPR level.

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Batch Record Manufacturing Instructions

STEP 268. Navigate to: Batch Production Record Manufacturing Instructions Tab

STEP 269. Log out and log back in as an Operator

STEP 270. Click for Step 10

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STEP 271. Enter “Room was cleaned @ 0600 by JDoe with 70% alcohol lot 222” in

Result field.

STEP 272. Click

STEP 273. Navigate to: Batch Production Record Manufacturing Instructions Tab

Application Rules for Batch Production Record Manufacturing Instructions:

The system will allow the operator to enter data in select fields in the BPR manufacturing

steps.

The operator may enter results, comments and deviations on the manufacturing step as

needed and update any attachments as necessary.

The operator may access the inventory use records for approved material lots and use

inventory in real time.

The material lot numbers, amounts used and signatures for each use within a

manufacturing instruction step will be auto-populated in the step.

Confirming a deviation comment adds a new signature button for a mandatory QA

approval of the deviation

Signature buttons signify that signature is required

Records with missing signatures for performer verifier or QA approval shall not be

Approved nor sent for use in inventory.

For steps with materials and the inventory box checked at the MPR level for those MPRs

with the Auto populate box checked, the automated action step will display.

Error messages will be displayed when the inventory amount used is not within the min

and max parameters set at the MPR level and deviations will be automatically opened.

Material uses for the part number of the selected step will be displayed on the step after

confirmation of uses. Multiple uses will be added to total the amount used for the step

and displayed as converted to the unit chosen at the Tmaterial screen.

STEP 274. Click for step 20

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STEP 275. Click

Application Rules for Inventory Use:

If the inventory checkbox was checked in the corresponding step in the MPR, then the

box will be checked in the BPR, alerting the operator to deplete the specified amount in

inventory. An Inventory button appears

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Selecting the Inventory button will bring up the inventory sub-screen with the material

that is available for use. The inventory can be depleted at this step in real time.

Depleting inventory will require operator signature.

STEP 276. Select the receipt number hyperlink for “Training-Raw Powder”

STEP 277. Click

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STEP 278. Select current date from calendar popup

STEP 279. Enter 3 in the Qty field

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STEP 280. Select Unit “g” from the drop down box

STEP 281. Enter “Training” in the Purpose field

STEP 282. Click


Note: if an amount outside of the min and max defined parameters for the step is

confirmed whether in one action or multiple actions, a deviation will be initiated.

STEP 284. Click

STEP 285. Click for “Performer Required”

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STEP 287. Hand control to another user to sign using their credentials, or toggle to

Quality/PM/ role and enter credentials for verifier and confirm

STEP 288. Select the appropriate navigation option in the “Action after Confirm”

dropdown

STEP 289. Click

STEP 290. Sign for any additional steps entered as an option

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Application Rules for Manufacturing Instruction Summary screen

Yellow checks indicate actions are required

Red checks indicate an error which stops the workflow

Green checks indicate all required actions for that step are completed

No check indicates that the step only requires that a result be entered

Note: Make sure to use material first and always confirm your results!

Batch Record Approval

STEP 291. Navigate to: Batch Production Record Executed BPR Review

STEP 292. Select sign button

STEP 293. Click enter credentials and confirm

STEP 294. Repeat for each mandated signature

Note: Signatures for MPR and BPR approvals are UserID-specific, not role

specific, so you must be signed in as the user requested.

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Application Rules

The system will lock a BPR including all its data once all assigned BPR approvers have

confirmed their approval signatures.

The first signature confirmation locks a batch

The system will allow a user to create a PDF report of the BPR record.

STEP 295. Navigate to the BPR Cover page tab

STEP 296. Click

Application Rules for adding Inventory

The system will allow a user to add the material from a BPR to the inventory as a WIP or

a Finished Goods type material.

The system will assign a Receipt Number to any WIP or Finished Goods material that is

added to inventory. (Requisition numbers for in-house produced goods FG/oWIP will be

0 as they were not requisitioned but manufactured with a batch record.)

STEP 297. Enter 3 into the Qty

STEP 298. Verify that “kg” is the unit

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STEP 299. Click


STEP 301. Click

Sale/Distribution of WIP/FG products

STEP 302. Navigate to Inventory Material Use

STEP 303. Select the update arrow for “Training - Finished Encapsulated Product”

STEP 304. Enter 1000 for the Qty Use

STEP 305. Enter “Sent to Distribution center” / “sold to…”

STEP 306. Select sign button and enter credentials.

STEP 307. Confirm

Audit Log

STEP 308. Navigate to Audit Audit Log

STEP 309. Enter your UserID in the person field

STEP 310. Select dates including today or dates of other data entry

STEP 311. Select types of access and screens and click search. Data appears

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STEP 312. Select Hyperlink for a URL

STEP 313. Navigate to Audit Audit Attribute

STEP 314. Select attribute from drop down and confirm

STEP 315. Select hyperlink for additional information

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Reports

Current Inventory, Equipment PM/CAL Dates, and Inventory in Quarantine are direct reports

that do not require entry of any additional data for the report to be run.

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Low inventory Levels Report requires user to select a below “stock %” on which to report.

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Traceability Reports require data to be selected before applicable data can be displayed. Select a

lot/production number to see what material lot #s were used to make the batch

Select a raw or WIP material to display all of the batches wherein that vendor lot # was used

Inventory value report assesses value through cost field

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Barcode

Barcode Scanning Functions: Personnel Badges/ Login and Material Labels.

(included in your subscription and must be toggled on by your InstantGMP support specialist)

Specs for barcode scanners: You may choose a standard USB or wireless scanner with a 3of9

font, which can be found online and in office stores for as little as $14 USD.

The two I tested with most are TaoTronics TT-BS012 and YHD 1100. The YHD is plug and play

and very inexpensive.

We recommend DYMO Label writer 450 and the “Badge Label” setting, DYMO labels #30857

Barcode scanner – Material Handling

Users can print a label with the status of a material and a barcode for each material receipt – at the Status

level. Go to the Inventory->Inventory Status. You can also ask your training specialist to toggle on the

feature to automatically print labels upon receipt in order to print all quarantine incoming material labels.

Select for a material receipt to be printed. Ensure that you select the correct printer and size the label

to the correct template. (this will vary depending on your version of adobe, printer, browser, OS, etc.) I

have chosen badge label.

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Select and scan the label. The Inventory Status page for that Receipt/Vendor lot#

will appear where the QM can change the status to “Approved.” A new label can be printed with

the new status for that Lot/Receipt number.

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Using inventory with the scanner

Select on Inventory Management -Inventory Use screen. Or Manufacturing instruction –

Inventory Use screen.

Scan the label. You can also type manually into the field and then select Scan button.

The Inventory Use screen for scanned receipt/vendor lot # will appear and operators may

manually enter how much material they used. Operators may manually sign or sign with their

badge.

Operators may sign with badge by scanning their badge on any signature screen or popup and

confirming. Remember to confirm record on main screen to save the signature to the record.

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To set up and print a badge, go to Setup->Personnel and select no earlier than today’s date for a

start date and an expiration date for the exp date. Select the “Create Badge” button.

Note: the option to create a badge only appears after the first time a personnel record is

confirmed. If this is a new record, go back into the record via the update icon and the option will

appear.

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Click

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Navigate back to the Personnel screen; select the print icon in the row for whom you’d like to

print a badge.

Return to any screen with a signature prompt and select the button.

Scan the badge.

Click

Additional training videos are available online at http://www.instantgmp.com/support

Additional remote training is available via Trainer’s calendar online,

http://www.instantgmp.com/support/appointment-request

or a quote can be requested via [email protected]

http://www.instantgmp.com/support

http://www.instantgmp.com/support/appointment-request

mailto:[email protected]

title: document no: csvp-um-igmp- csvp 3.000.001 manual … · 2019-02-26 · title: csvp –...

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