kisi kisi urs

7/25/2019 Kisi Kisi URS

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User Requirement Specifications

Tetra Pak Stainless EquipmentAgus Rascana

Tangerang, September 15th, 2015

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URS-User Requirement Spesifications


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PreliminaryStudy

FeasibilityStudy

EngineeringConceptual

Flowchart of Buying Process

Rooms Layout, Personal& Material Flow, Plant

Layout, Utilities , HVAC,VMP, URS, Process

Basic Design/Engineering

BPOM &HeadquarterApprovals

VMP, URS

DetailedEngineering

BPOMApproval

ProductCapacity

Market SizeValidation

master Plan

DQ, Plant Layout,Architecture, Cost ofBudget Investment,

VMP, URS

IMB,

AMDAL,BKPM

Approvals

RISK

HVACElectrical

B AutomationWaste

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TenderCompile All Designs

Civil Architecture

Construction

Installation completedIQ, OQ, PQ

Process Validation

Stability TestResult

CommercialProduct

VMPNew ProductFormulation

NALYSIS

FacilityImprovement

DQ

BPOM

Approvalfor use offacility

Note :

: Consultant or supplier roles

: Done by Customer

Plant Design,Automation and

PlantIntegration,

Building

Bidding Detail:

Engineering& Cost Approval

DetailedEngineering& Approval

BPOMApproval forproduction

StabilityTest

ProcessingP Automation

Plant Integration


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Illustration of the validation and

qualification principles in GMP.

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Ref. ISPE


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Main Propose and Validation

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The Risk - Based Verification Process

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Ref. ASTM


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Scope and ApproachRequirements

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New commercial manufacturing and modification to

existing regulated manufacturing facilities

Planning, specification, design, and delivery

(harmonized) with GAMP 5

Scope

of the validation life cycle on which processvalidation is built

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(Product) User Requirements notFormally Documented

Protocols Developed fromTemplates IQ/OQ Protocols

Process Requirements Documented,Approved

Risk Assessments Determine CriticalAspects of Design

Traditional & RBA Based on ASTM E 2500

Approach and Method Validation

Preapproved Commissioning notLeveraged

Engineering And ValidationPersonnel Often Distinct

Emphasis on Documents NotSystem Performance

Engineering Testing (Commissioning)Verification

All Documents with Technical MeritUsed as Evidence of Fitness or Use

Emphasis on Meeting ProcessRequirements

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1. Introduction

2. Overview Of The

Lifecycle

3. Requirements

4. Specification & Design

8. Good EngineeringPractice

9 . Design Review

10. Change Management

11--15. Appendices

Summaries of requirement

5. Verification, Acceptanceand Release

6. Continual Improvement

7. Quality Risk

Management

16. Appendix 6 Glossaryand Acronyms

17. Appendix 7References

Note : Automation dealtwith throughout eachchapter

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ASTM- Risk Based Approach

ASTM Process

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Supportingactivities

Ref. ISPE


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Production Functionality Review

Objective To evaluate the ability of the functional design documents to

meet production related requirements in contract and toidentify deviations (if any) and agree necessary actions.

Requirements

Exhibits: Design Requirements Technical Description and Drawing list Specification of Equipment and Services

Commissioning Criteria and Performance Targets

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Production Functionality Review

Scope The works or agreed sections thereof as per documents

listed below. Process Technology Diagram Mass balance Production Time Schedule or manufacturin

characteristics Production Block Diagram Functional Diagram Automation System Configuration Machinery layout Single Line Diagram

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Next

Next and detail See file P0031-033_QualityAssurancePlan.doc

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Risk based approach


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Validation Master Plan

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Key Elements of validation Programme

The validation master plan (VMP) should reflectthe key elements of the validation programme.It should be concise and clear and contain atleast the following: a validation policy


organ zat ona structure o va at on act v t es summary of facilities, systems, equipment and processes

validated and to be validated documentation format (e.g. protocol and report format) planning and scheduling

change control references to existing documents.

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1. Introduction

2. Scope

3. Facility Description

4. Commissioning

9. List of RequiredStandard Operating

Procedures

10. Equipment andUtility System

Typical VMP Contents


.

6. Process Validation

7. Computer SystemValidation

8. List of RequiredProtocols andProcedures

escr p ons

11. Computer SystemDescription

12. Other cGMP

Programs 13. References

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Validation references

World Health Organization, WHO Technical Report

Series, No. 937, 2006, Annex 4, Supplementaryguidelines on good manufacturing practices:Validation

World Health Or anization WHO Technical Re ort


Series, No. 937, 2006, Annex 4, Supplementaryguidelines on good manufacturing practices:Validation, Appendix 7, Non-sterile processvalidation

WHO good manufacturing practices: water forpharmaceutical use. Geneva, World, HealthOrganization 2005 (WHO Technical Report Series,

No. 929), Annex 3.AR/2015-09-15



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Quality Assurance &

Scope of Supply

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Productions solutions for Oral products

PW Generator

Vacuum MixingModule

CIP Module

PW tankand Loop module

Holding Module

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Production solutions for Parenteral

products

LVP Module

PSG andWFI Loop

LVP FillingMachine

SVP Module

CIP SIP ModuleSVP Filling

Machine

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Complete line solutions

Inte rated automation

Traceability

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User Requirement

Specification

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Product or application

General requirements for pharmaceutical watersystems

Water quality specifications Drinking-water Purified water

Equipment or systems is suitable for the

intended purpose

Highly purified water Water for injections Other grades of water

Application of specific water to processes and

dosage forms

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Product or application

Water purification methods General considerations

Production of drinking-water Production of purified water Production of highly purified water Production of water for in ections

Equipment or systems is suitable for the

intended purpose

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The Risk - Based Verification Process

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Ref. ASTM


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Quality Assurance

Plan

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Design Review and Risk Assessments

Review of Production Solution Functionality Production Functionality review Operation Functionality review

Review of Technical Design

Hygienic Risk Assessment

Health & Safety Risk Assessment

Project Quality Assurance Plan

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Implementation

Supplier selection

Procedure, Facility

Certification, etc.

Testing


r party nspect ons

Factory Acceptance Test FAT - Dry

Factory Acceptance Test FAT Wet

Factory Acceptance Test FAT Product Test

Waste handling

Etc.

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Installation Completion

Pre-delivery Inspections

Factory Acceptance Test (FAT)

Box Opening Inspection

Health & Safety Risk Validation


omp ete nsta at on nspect on

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Commissioning

Commissioning Test

Performance Test


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Performance Validation

Performance Test


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Thank you

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