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Supplementary Training Modules on

Good Manufacturing Practice

Validation

WHO Technical Report Series,


No. 937, 2006. Annex 4.

Validation | Slide 1 of 27 August 2006


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

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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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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

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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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Validation
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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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

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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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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

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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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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

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Defined schedule

Periodic

Requalification After change

8.1 – 8.3

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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

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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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Validation

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Validation

Group session

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