Transcription of Annex 4 Supplementary guidelines on good …
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Annex 4 Supplementary guidelines on good …
107 World Health OrganizationWHO Technical Report Series, No. 937, 2006 Annex 4 Supplementary guidelines on good manufacturing practices: validation1. Introduction 2. Scope 3. Glossary 4. Relationship between validation and qualifi cation 5. Validation Approaches to validation Scope of validation 6. Qualifi cation 7. Calibration and verifi cation 8. Validation master plan 9.
112 verifi cation The application of methods, procedures, tests and other evaluations, in ad-dition to monitoring, to determine compliance with the GMP principles.
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