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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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