Equipment Qualification:  

Regulatory requirement,
Business need or Common
Sense
Swapnil Ballal
Intas Biopharmaceuticals
Ltd.
Nov 09
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 for
the weights set used for checking the balance.
 The calibration procedure for HPLC systems is inadequate in that it did not
include integrator and detector’s linearity, injector’s reproducibility, and
accuracy of temperature settings for column heater and detector.
 There are no predetermined acceptance criteria for the HPLC auto sampler
calibration.
 Procedures for UV/VIS Spectrophotometer only assesses linearity using
alkaline potassium chromate solution at one wavelength when analytical
tests are performed at various wavelengths. The procedures does not
include functional tests such as wavelength accuracy, photometric
accuracy, and reproducibility within ranges of intended use for the
instrument.
 Calibration raw data and results obtained for the performance qualification
of analytical instruments is not being checked for accuracy and
completeness by a second analyst or laboratory supervisor.

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So What is Equipment
Qualification?
Equipment Qualification is used as an
umbrella term covering the steps that
ensure an instrument or equipment is
appropriate for its intended use.

The user has the ultimate responsibility for

the accuracy of results and for the
qualification of his/her equipment.

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And What is
QUALIFICATION?
Qualification involves testing equipment to
demonstrate that they do what they are suppose
to 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 is”
And 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 gives

predictable 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, there
must be pre-determined requirements – “This is
what it is suppose to be” and corresponding tests
“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 to

Qualification

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User Requirement
The document exits to be read not 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
 Don’t copy Vendor Specifications !
 Need not be technical.

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The Qualification Model
User
Requirements

ISSUE THE URS TO SUPPLIERS !!!!

Its NOT for QA or Audiors

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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 requirement
at design stage

We generally have both the Functional Requirement

and User Specification in one

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The Qualification Model

User
Requirements

Functional
Requirements

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Design Qualification
 Defines how the Specification defined in user
requirements are to be implemented
 Define what objects to be used and their
configuration and orientation
 Ensures that instruments have all the necessary
functions and performance criteria that will enable
them to be successfully implemented for the intended
application and to meet user requirements.
Can be carried out by Vendor?
Can you allow your car dealer to select the suitable
make and model for you?

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The Qualification Model

User
Requirements

Functional
Requirements

Design
Qualification

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Factory Acceptance Testing
(FAT)
- Factory Acceptance Testing – Larger Custom
designed equipment
- Predefined protocol and acceptance criteria
- Several FAT – at different critical stage of
manufacturing
- Generally not for Commercial Off the Shelf
equipment (COTS)

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The Qualification Model
User
Requirements

Functional
Requirements

Design
Qualification

Factory Acceptance
Build
Testing

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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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The Qualification Model

User
Requirements

Functional
Requirements

Design
Qualification
Pre Installation Checks

Factory Acceptance Testing Build

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Installation Qualification
 Instrument is received as designed and specified
 It is properly installed in the selected
environment
 The environment is suitable for the operation and
use of the instrument.

Verify Static Attributes

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The Qualification Model
User
Requirements

Functional
Requirements

Design Installation
Qualification Qualification

Pre Installation Checks

Factory Acceptance Testing Build

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Operational Qualification

Demonstrates that an instrument will function

according to its Operational Specification (as
described by manufacturer) in the selected
environment.

Testing may be quite extensive if the instrument

is to be used for all types of applications like in
Development 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 (Attach
calibration 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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The Qualification Model
User
Requirements

Functional Operational
Requirements Qualification

Design Installation
Qualification Qualification

Pre Installation Checks

Factory Acceptance Testing Build

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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 are
similar 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

User Performance
Requirements Qualification

Functional Operational
Requirements Qualification

Design Installation
Qualification Qualification

Pre Installation Checks

Factory Acceptance Testing Build

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Requalification
 Not required if PQ or alternative modes in
place to verify qualified state
 Required for
 Repairs
 Relocation
 Change in application/ user requirement

 Extent of Requalification – Decided on case

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, as
installed or modified, comply with the approved design and the manufacturer’s
recommendations.

 Operational Qualification (OQ)

The documented verification that the facilities, systems and equipment, as
installed or modified, perform as intended throughout the anticipated operating
ranges.

 Performance Qualification (PQ)

The documented verification that the facilities, systems and equipment, as
connected together, can perform effectively and reproducibly, based on the
approved process method and product specification.

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

Manufacturing Practice

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Visual Review

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Further Reading
All 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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