文档介绍：Validation
Supplementary Training Modules on Good Manufacturing Practice
WHO Technical Report Series, No. 937, 2006. Annex 4.
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
Qualification of systems and equipment Part 6
Supplementary Training Modules on Good Manufacturing Practice
WHO Technical Report Series, No. 937, 2006. Annex 4. Appendix 6.
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
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
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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
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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
. electrical supply systems
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Validation
General (continued)
Systems: Qualified before equipment
Equipment: Qualified before routine use
Systems and equipment: Periodic requalification, as well as requalification after chan