Supplementary Training Modules on
Good Manufacturing Practice
Validation
WHO Technical Report Series,
No. 937, 2006. Annex 4.
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 Part 1. General overview on qualification and validation
 Part 2. Qualification of HVAC and water systems
 Part 3. Cleaning validation
 Part 4. Analytical method validation
 Part 5. Computerized system validation
 Part 6. Qualification of systems and equipment
 Part 7. Non sterile product process validation
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Supplementary Training Modules on
Good Manufacturing Practice
Qualification of systems
and equipment
Part 6
WHO Technical Report Series, No. 937,
2006. Annex 4. Appendix 6.
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Objectives
To discuss the principles of qualification of systems and
equipment, with specific focus on:
 The different stages of qualification
 Requalification and
 Qualification of “in use” systems and equipment
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Principle
 Systems and equipment: Appropriately designed, located,
installed, operated and maintained
 Critical systems and equipment – should be qualified
 May include, where appropriate:
– Water purification systems, air-handling systems,
autoclaves, coating machines
 Continued suitable performance needed
– Why? To ensure batch-to-batch consistency
1.1 – 1.3
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Scope
 Guidelines describe the general aspects of qualification for
systems and equipment
 Normally qualification would be applicable to critical systems
and equipment whose performance may have an impact on the
quality of the product
2.1 – 2.2
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General
 Qualification policy for systems and equipment
 To include instruments used in production and quality control
 New systems and equipment: All stages of qualification
applicable (DQ, IQ, OQ and PQ)
 In some cases: Not all stages of qualification may be required
– e.g. electrical supply systems
3.1 – 3.4
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General (continued)
 Systems: Qualified before equipment
 Equipment: Qualified before routine use
 Systems and equipment: Periodic requalification, as well as
requalification after change
 Certain stages done by the supplier or a third party
 Maintain the relevant documentation, e.g.
– standard operating procedures (SOPs), specifications and
acceptance criteria, certificates and manuals
3.5 – 3.9
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General (continued)
 Qualification should be done in accordance with predetermined
and approved qualification protocols
 The results of the qualification should be recorded and reflected
in qualification reports
 The extent of the qualification should be based on the criticality
of a system or equipment, e.g.
– Blenders, autoclaves or computerized systems
3.10 – 3.11
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Blender
 Discuss the approach of
qualification of a newly
installed blender
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Stages of qualification
Design qualification
Installation qualification
Operational qualification
Performance qualification
3.11
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Stages of qualification
Design qualification
Installation qualification
Operational qualification
Performance qualification
Change control
3.11.
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Design qualification
 User requirements should be considered when deciding on the
specific design of a system or equipment
 A suitable supplier should be selected for the appropriate
system or equipment (approved vendor)
4.1 – 4.2
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Installation qualification
 Correct installation as per plan and protocol
 Normally advised to prepare requirements for calibration,
maintenance and cleaning at this stage
 Identification and verification of all system elements, parts,
services, controls, gauges and other components
 Calibrate the measuring, control and indicating devices
– against appropriate, traceable national or international
standards
5.1 – 5.4
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Installation qualification (2)
 Documented records for the installation
– installation qualification report
 Indicate satisfactory installation
 Include details, e.g.
– The supplier and manufacturer
– System or equipment name, model and serial number
– Date of installation
– Spare parts, relevant procedures and certificates
5.5
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The handout shows a typical format for
"An installation qualification protocol / report"
 It reflects the minimum information that should be included
 This is an example – and should be used as such
 Specific formats need to be designed for a specific system or
piece of equipment
5.5
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Operational qualification
 Systems and equipment should operate correctly – operation
verified as in the qualification protocol
 Studies on critical variable to include conditions encompassing
upper and lower operating limits and circumstances (i.e.
“worst case conditions”)
 To include verification of operation of all system elements, parts,
services, controls, gauges and other components
6.1 – 6.3
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Operational qualification (2)
 Documented records (Operational qualification report)
 Finalize and approve SOP (operation)
 Training of operators provided – training records
 Systems and equipment released for routine use after
completion of operational qualification, provided that:
– All calibration, cleaning, maintenance, training and related
tests and results were found to be acceptable
6.4 – 6.7
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The handout shows a typical format for:
"An operational qualification protocol / report"
 It reflects the minimum information that should be included
 This is an example – and should be used as such
 Specific formats need to be designed for a specific system or
piece of equipment
6.7
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Performance qualification
 Systems and equipment should consistently perform in
accordance with design specifications – verified in accordance
with a performance qualification protocol
 Documented records – performance qualification report
 Show satisfactory performance over a period of time
 Manufacturers to justify the selected period
7.1 – 7.2
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The handout shows a typical format for:
"A performance qualification protocol / report"
 It reflects the minimum information that should be included
 This is an example – and should be used as such
 Specific formats need to be designed for a specific system or
piece of equipment
7.2
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Defined schedule
Periodic
Requalification
After change
8.1 – 8.3
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Defined schedule
Frequency based on
Factors
Results of calibration
maintenance,
verification
Periodic
Requalification
After change
Extent based on
Risk assessment
Part of
Change control procedure
8.1 – 8.3
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 What about "old manufacturers" who have not
performed DQ, or IQ for existing, in-use systems
and/or equipment?
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Qualification of “in-use” systems and equipment
 Data to support and verify the suitable operation and
performance of systems and equipment
 Should include operating parameters and limits for critical
variables, calibration, maintenance and preventive maintenance,
standard operating procedures (SOPs) and records
9.1 – 9.2
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Group session
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