Transcription of Annex 4 Supplementary guidelines on good …
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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.
108 1. Introduction Validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance programme associated with a
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