WHO: Supplementary Training Modules on Good Manufacturing Practice

1. Supplementary Training Modules on
Good Manufacturing Practice
Validation
WHO Technical Report Series,
No. 937, 2006. Annex 4.
Validation | Slide 1 of 27 August 2006

2. Validation
 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
Validation | Slide 2 of 27 August 2006

3. 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.
Validation | Slide 3 of 27 August 2006

4. Validation
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
Validation | Slide 4 of 27 August 2006

5. Validation
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
Validation | Slide 5 of 27 August 2006

6. Validation
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
Validation | Slide 6 of 27 August 2006

7. Validation
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
Validation | Slide 7 of 27 August 2006

8. Validation
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
Validation | Slide 8 of 27 August 2006

9. Validation
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
Validation | Slide 9 of 27 August 2006

10. Validation
Blender
 Discuss the approach of
qualification of a newly
installed blender
Validation | Slide 10 of 27 August 2006

11. Validation
Stages of qualification
Design qualification
Installation qualification
Operational qualification
Performance qualification
3.11
Validation | Slide 11 of 27 August 2006

12. Validation
Stages of qualification
Design qualification
Installation qualification
Operational qualification
Performance qualification Change control
3.11.
Validation | Slide 12 of 27 August 2006

13. Validation
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
Validation | Slide 13 of 27 August 2006

14. Validation
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
Validation | Slide 14 of 27 August 2006

15. Validation
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
Validation | Slide 15 of 27 August 2006

16. Validation
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
Validation | Slide 16 of 27 August 2006

17. Validation
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
Validation | Slide 17 of 27 August 2006

18. Validation
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
Validation | Slide 18 of 27 August 2006

19. Validation
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
Validation | Slide 19 of 27 August 2006

20. Validation
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
Validation | Slide 20 of 27 August 2006

21. Validation
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
Validation | Slide 21 of 27 August 2006

22. Validation
Defined schedule
Periodic
Requalification After change
8.1 – 8.3
Validation | Slide 22 of 27 August 2006

23. Validation
Results of calibration
Defined schedule , maintenance
verification
Frequency based on
Factors
Periodic
Requalification After change
Extent based on
Risk assessment
Part of
Change control procedure
8.1 – 8.3
Validation | Slide 23 of 27 August 2006

24. Validation
What about "old manufacturers" who have not
performed DQ, or IQ for existing, in-use systems
and/or equipment?
Validation | Slide 24 of 27 August 2006

25. Validation
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
Validation | Slide 25 of 27 August 2006

26. Validation
Validation | Slide 26 of 27 August 2006

27. Validation
Group session
Validation | Slide 27 of 27 August 2006