24159419 Equipment Qualification

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Equipment Qualification:

Regulatory requirement, Business need or

Common Sense

Swapnil BallalIntas Biopharmaceuticals Ltd.

Nov 09


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4-May-12 S.Ballal, Intas Biopharmaceuticals Ltd. 2 of 28

FDA Warning Letters related to EQ Inadequate laboratory equipment calibration program: failure to have

written procedures describing specific calibration instructions and limits . Failure to conform to the USP section 41 for weight and balance

determination. The inspection revealed that erroneous values are being used to perform

the minimum weight studies. No certification to a recognized standard forthe weights set used for checking the balance.

The calibration procedure for HPLC systems is inadequate in that it did notinclude integrator and detectors linearity, injectors reproducibility, andaccuracy of temperature settings for column heater and detector.

There are no predetermined acceptance criteria for the HPLC auto samplercalibration.

Procedures for UV/VIS Spectrophotometer only assesses linearity usingalkaline potassium chromate solution at one wavelength when analytical

tests are performed at various wavelengths. The procedures does notinclude functional tests such as wavelength accuracy, photometricaccuracy, and reproducibility within ranges of intended use for theinstrument.

Calibration raw data and results obtained for the performance qualificationof analytical instruments is not being checked for accuracy andcompleteness by a second analyst or laboratory supervisor.


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So What is Equipment Qualification?

Equipment Qualification is used as anumbrella term covering the steps thatensure an instrument or equipment is

appropriate for its intended use.

The user has the ultimate responsibility forthe accuracy of results and for thequalification of his/her equipment.


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And What is QUALIFICATION?

Qualification involves testing equipment todemonstrate that they do what they are supposeto do.

QUALIFICATION= TESTING

It must be first stipulated This is what it is suppose

to be and then tested to show This is what it isAnd not This is what it is, which must be what it is

suppose to be


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Why Test ?

When a system is tested a BASELINE is achieved

For a given set of inputs- system givespredictable response and known output

Valid over time

Till the system is not changed

Once changed, the results may not be valid.

Test after each change or Manage Change ??


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Requirements

In order to formulate meaningful testing, theremust be pre-determined requirements This iswhat it is suppose to be and correspondingtests This is what it is

No specified Requirement- No meaningful testing

No meaningful testing- No tested baseline

No tested baseline Nothing to manage

Nothing to manage System not under Control

Requirements are Fundamental toQualification


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User Requirement

The document exits to be readnot written

To convey information on what is required

Defines Process Requirements What is required

Simple Short statements

Describe what is needed

Keep each premise/idea separate

Stick to the facts

Dont copy Vendor Specifications !

Need not be technical.



The Qualification Model

ISSUE THE URS TO SUPPLIERS !!!!

Its NOT for QA or Audiors

UserRequirements



Functional Requirements

What has to be done to implement the process,Does not define how to do it

Also referred to as Conceptual Design

Can result in multiple solution for a requirementat design stage

We generally have both the Functional Requirement

and User Specification in one




UserRequirements

FunctionalRequirements



Design Qualification

Defines how the Specification defined in userrequirements are to be implemented

Define what objects to be used and theirconfiguration and orientation

Ensures that instruments have all the necessaryfunctions and performance criteria that willenable them to be successfully implemented forthe intended application and to meet userrequirements.

Can be carried out by Vendor?

Can you allow your car dealer to select the suitablemake and model for you?




UserRequirements

Functional

Requirements

Design

Qualification



Factory Acceptance Testing (FAT)

- Factory Acceptance Testing Larger Customdesigned equipment

- Predefined protocol and acceptance criteria

- Several FAT at different critical stage ofmanufacturing

- Generally not for Commercial Off the Shelf

equipment (COTS)




DesignQualification

Factory AcceptanceTesting

Build

UserRequirements

FunctionalRequirements


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Pre Installation Checks

Vendor provided/Self Generated

Check for

Space / Environment

Power Type, Quality, connections Utility connections flow, end connections

Drains

IT needs

Travel Path


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DesignQualification

Factory Acceptance Testing Build

UserRequirements

Functional

Requirements


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Installation Qualification

Instrument is received as designed and specified

It is properly installed in the selectedenvironment

The environment is suitable for the operation anduse of the instrument.

Verify Static Attributes


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Design

Qualification


UserRequirements

Functional

Requirements

Installation

Qualification


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Operational Qualification

Demonstrates that an instrument will functionaccording to its Operational Specification (asdescribed by manufacturer) in the selected

environment.

Testing may be quite extensive if the instrumentis to be used for all types of applications like inDevelopment Labs


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Operational Qualification

OQ for a centrifuge Does the centrifuge turn on and off

Spin at programmed speed & temperature

Brake as set

Retain programming

Describe specifications to be tested

Accuracy of settings, maintenance of temperature etc.

Has the equipment been calibrated: By whom (Attachcalibration documents)

Has an SOP been written: If no, then must be done

before equipment put into use Individual completing this section

Training


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Design

Qualification


UserRequirements

Functional

Requirements

Installation

Qualification

Operational

Qualification


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Performance Qualification Does the equipment function correctly and consistently for

the Intended Application

Important here is the word consistently.

PQ should always be performed under conditions that aresimilar operation.

The test frequency is much higher than for OQ.

In practice, OQ and PQ frequently blend together. Example:linearity and repeatability tests

Analogous to Validation - emphasis on a piece of equipment

and not a process

Holistic approach is Acceptable & Preferred

System suitability test Part of PQ


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The V -Model of EQ


Design

Qualification


UserRequirements

Functional

Requirements

Installation

Qualification

Operational

Qualification

PerformanceQualification


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Requalification

Not required if PQ or alternative modes inplace to verify qualified state

Required for

Repairs Relocation

Change in application/ user requirement

Extent of Requalification Decided oncase to case- can be limited to module


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Current Approaches

Impact Assessment

ISPE initiated

To define Focus & Extent of Qualification

Risk Based Qualification Identify the risky areas, components

Set up tests to address/ control

Minimal or no testing for low risk components

Combined CQV (Commissioning,Qualification& Validation)

Use of test carried out in earlier testing for EQ


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Definition Review Design qualification (DQ)

The documented verification that the proposed design of the facilities,systems and equipment is suitable for the intended purpose.

Installation Qualification (IQ)The documented verification that the facilities, systems and equipment, asinstalled or modified, comply with the approved design and the

manufacturers recommendations.

Operational Qualification (OQ)The documented verification that the facilities, systems and equipment, asinstalled or modified, perform as intended throughout the anticipatedoperating ranges.

Performance Qualification (PQ)The documented verification that the facilities, systems and equipment, asconnected together, can perform effectively and reproducibly, based onthe approved process method and product specification.

Ref: Qualification and validation, Annex 15 to the EU Guide to GoodManufacturing Practice


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Visual Review


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4 M 12 S B ll l I t Bi h ti l Ltd 28 f 28

Further ReadingAll are hyperlinked to the files.

Risk-Based Commissioning & Qualification Benchmarking

Equipment Qualification Guide

Validation Part 6 -WHO

Equip. Qualification - PACT Webinar January 29, 2009

Equipment Qualification: Meeting Your Demands

The Process of Equipment Qualification
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