equipment qualification fit for intended use 22_roo… · · 2017-03-22equipment qualification...

Equipment Qualification

Fit for Intended Use

Presented by Justin RooseHead Validation Engineer – Product Quality Assurance (Global Compliance)

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Session

Agenda

Introductions

Equipment Validation Requirements

Equipment Validation Execution

Installation Qualification

Operation Qualification

Performance Qualification

Deviations

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WHAT IS VALIDATION AND

WHY DO WE DO IT?

What is Validation

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Documented evidence that

processes, procedures, and

equipment lead to predetermined

expectations, specifications and

quality attributes.

What is Equipment Qualification

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Equipment used in the manufacture,

processing, packing, or holding of a drug

product shall be of appropriate design,

adequate size, and suitably located to

facilitate operations for its intended use

and for its cleaning and maintenance.

21 CFR 211.63

Why Validate

Validation ensures that the processes and

the equipment that are in place (or being

installed) function to meet the quality

requirements you committed to…

• your customers,

• government agencies,

• your manufacturing staff.

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Fit For Intended Use

• What is the definition?

FIT FOR INTENDED USE

Definition

• Capable to the job we want it to do?

• Does it do the job we bought it to do?

• Does it NOT do what we don’t want it to do?

Applies to New & Legacy Equipment Qual

Needs to be Defined up front in the process

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FIT FOR INTENDED USE

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WHERE & WHEN DO YOU

HAVE TO VALIDATE

Validation

Scope of Validation

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Equipment

Facilities & Utilities

Process & Packaging

Control & Information

Systems Software

Test Methods

Laboratory Equipment

Sanitizing

Cleaning

Scope of Validation

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Company Validation Policy

• Should include

• New and Legacy Equipment

• Risk Based Approach

WHAT IS THE EQUIPMENT

QUALIFICATION PROCESS

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MASTER PLAN

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Sanitary

Design

USP

Requirements

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Validation

Protocol

OSHA

Requirements Equipment

Codes

Industry

Design

Standards

ISO

Standards

Equipment

SpecificationsUser

Requirement

Documents

Intended

Use

Requirements Equipment

Manual

Pre-Qualification Activities

FAT

• FACTORY ACCEPTANCE TEST

• The testing of equipment for performance and reliability performed at the vendor before authorizing delivery.

SAT

• SITE ACCEPTANCE TEST

• The inspection and testing of equipment at the manufacturing site (in the plant) after delivery, installation, and debug to verify it is in the same condition as in the FAT.

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Qualification Activities

1. Write Protocol • Based on Fit for Use specification

• Based on other requirements

2. Execute Protocol

3. Address any Deviations in the Protocol

4. Create Final Report Summarizing the

Protocol

5. Close Out Qualification

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What does it take to do an

Equipment Qualification?

Equipment Qualification IQ/OQ/PQ are Built …

From the User Requirements Documents

From Manuals

To encompass range of products to be produced with subject equipment

For cGMP requirements

Data is obtained from the FAT and SAT results to update the final IQ, OQ, PQ protocols

For functional and debugged equipment

“ready for validation”

#1 Cause of Deviations

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EQUIPMENT

QUALIFICATION

REQUIREMENTS

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Lets focus on how to test

FIT for Intended USE?

INSTALLATION

QUALIFICATION

IQ OQ PQ

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Equipment Qualification (IQ)

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Documentation verification that all

aspects of a system, facility, utility or

equipment that can affect product

quality are installed according to

specifications and design criteria.

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Installation Qualification (IQ)

Equipment VerificationA• Basic Equipment Info: Make, Model, Serial Number, etc. – FIT FOR

USE?

Drawing List and DocumentationB

• Update and As-built

• P&IDs, Wiring/Logic/Loop Diagrams, Plan View

• Can be completed during SAT

Equipment Install VerificationC

• Ensure environment is suitable (outdoors, XP) – FIT FOR USE?

• Accessible for cleaning/maintenance – FIT FOR USE?

• Appears clearly labeled (ID, controls, safety)

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Materials of Construction D• Includes lubricants (food grade – USDA H1)– FIT FOR USE?

• All product contact parts (i.e., Pump, Filler, Mix Tank)– FIT FOR USE?

• Attach material certs (preferred) or manufacturer material certification

Utilities VerificationE• All critical utilities required for proper operation of equipment

(i.e., electrical, water, compressed air, etc.)– FIT FOR USE?

Computerized Controls HW/SWF• For PLC or complex controls systems

• PLC software (i.e., title, version)

• Hardware – make/model (i.e., PLC, OIT, I/O Boards, Power Supplies)

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Calibration – RANGES FIT FOR USE?G

• Critical Process Devices & Test Equipment

• Calibration for all process devices (Temp, Pressure, etc.)

• Any devices used in execution or measuring data (tachometer, caliper, etc.)

Preventive Maintenance H

• Document all

• Must be scheduled frequency

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Spare Parts I

• Critical Spares should be identified

• List of Spare Parts should be available in the Maintenance Shop, and stocked – Fit For Use?

• Product Contact Materials – Fit For Use?

Equipment Procedures J

• Equipment Operation SOPs – Fit For Use?

• Equipment Use Logs

• Cleaning SOPs – Fit For Use?


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I/O PLC Connectivity K

• All PLC I/Os

• Can be performed by vendor or during SAT

• Can be printed with “Performed by” sign-off/date by vendor

• Empty addresses can be NAP’d

• Simulated or real-time testing

• Simulate signal with software (i.e., force signal in PLC)

• Manipulate field device (obstruct or “make” photo-eye)

• Simulate signal with equipment/instrument (i.e., strobe generator)

• Manipulate using OIT

OPERATIONAL

QUALIFICATION

IQ OQ PQ

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Operation Qualification (OQ)

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Documented verification that all aspects

and functions of a system, facility, utility

or equipment that can affect product

quality operate properly within all

anticipated operating ranges as

required by the process, capability,

procedures and design specification.


Functional VerificationL

• Challenge the equipment operational ranges

• Vendor operational ranges

• Your Specifications – Fit For Use?

• As wide-range as possible – Fit For Use?

• Based on our equipment requirements – Fit For Use?

• Should be statistical – Fit For Use?

• FAT, SAT, Engineering/Commissioning Studies, testing may satisfy OQ testing requirements and follow GDPs

• FIT FOR INTENDED USE

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Password Security Verification (if applicable)M• Challenge all system security features

• PLC/OIT Password level challenge (do not record passwords in the protocol)

Safety & Alarm Verification N• Challenge all critical alarms including audible and visual

indicators

• Includes E-Stop / Open Door / Main-line

Controls Verification (if applicable)O• Challenge all controls (could be many pages) – Fit For

Use?

• “Push this button” > This screen appears

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PRACTICE

ACTIVITY

IQ OQ PQ

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Functional Test Example… What would our

functional tests be?

• #1 Filler:

• New filler for moderate-high speed line;

• The filler itself is designed to operate from 20-230

upm (units per minute);

• The remaining line equipment runs 60-110 upm;

• Container sizes are specified to range from 2 ml.

to 200 ml;

• Assume specific gravity of 0.9 for all products.

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• #1 Filler:

• Challenge product container fill weight

capability

• Run 2 ml bottles at 20 and 230 units per

minute

• Run 200 ml bottles at 20 and 230 units per

minute

• Sample size based on statistics of the lot

size (CpK, etc…)

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• #2 Mix Vessel:

• New custom designed 12,000L;

• Raw materials are added via tank drop pipe or

through a 30” manway;

• The tank is jacketed;

• Jacket Service hot & cold water and steam;

• A turbine mixer, attached to 40hp electric variable

frequency drive (VFD) motor,

• RPM range of “0”-260 rpm.

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• #2 Mix Vessel:

• Smallest volume to submerge agitator (min fill

volume)

• Max Volume

• Heating (max temp and temp ramp) Ramp Rate

• Cooling (min temp and max temp ramp) Ramp

Rate

• Agitation – with high and low viscosity products

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VALIDATION

EXECUTION

IQ OQ PQ

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Performance Qualification (PQ)

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Documented verification that all

aspects of a system, facility, utility or

equipment that can affect product

quality produce the required output

over an extended period under

typical operating conditions and

interferences.

Performance Qualification (PQ)

Performance ChallengeP

• Prove the Equipment can work:• For an extended period of time;

• With variety of starts and stops,

• Multiple formulas..

• Challenges equipment / equipment train for extended period under typical operating conditions (to simulate real-world usage)

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DEVIATIONS

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Deviations

• Failure to meet Acceptance Criteria

• Change in testing approach/method

• Equipment does not meet its intended use

Typical Deviations

• Failure / deviation (cite protocol requirements)?

• Investigation

• Corrective Action / Preventative Action

When there is a deviation…

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WRAP UPQuestions & Answers

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