24159419 equipment qualification
TRANSCRIPT
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Equipment Qualification:
Regulatory requirement, Business need or
Common Sense
Swapnil BallalIntas Biopharmaceuticals Ltd.
Nov 09
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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.
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The Qualification Model
ISSUE THE URS TO SUPPLIERS !!!!
Its NOT for QA or Audiors
UserRequirements
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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 requirementat design stage
We generally have both the Functional Requirement
and User Specification in one
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The Qualification Model
UserRequirements
FunctionalRequirements
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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?
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The Qualification Model
UserRequirements
Functional
Requirements
Design
Qualification
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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)
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The Qualification Model
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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The Qualification Model
Pre Installation Checks
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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The Qualification Model
Pre Installation Checks
Design
Qualification
Factory Acceptance Testing Build
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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The Qualification Model
Pre Installation Checks
Design
Qualification
Factory Acceptance Testing Build
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
Pre Installation Checks
Design
Qualification
Factory Acceptance Testing Build
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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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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