Transcription of Annex 2 W HO good manufacturing practices for active ...
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Annex 2 W HO good manufacturing practices for active ...
130 World Health OrganizationWHO Technical Report Series, No. 957, 2010 Annex 2W HO good manufacturing practices for active pharmaceutical ingredients1. Introduction Objective Regulatory applicability Scope2. Quality management Principles Responsibilities of the quality unit(s) Responsibility for production activities Internal audits (self-inspection) Product quality review3. Personnel Personnel qualifi cations Personnel hygiene Consultants4. Buildings and facilities Design and construction Utilities Water Containment Lighting Sewage and refuse Sanitation and maintenance5. Process equipment Design and construction Equipment maintenance and cleaning Calibration Computerized systems6. Documentation and records Documentation system and specifi cations Equipment cleaning and use record Records of raw materials, intermediates, API labelling and packaging materials Master production instructions (master production and control records) Batch production records (batch production and control records) Laboratory control 11:03131 Batch production record review7.
Annex 2 W HO good manufacturing practices for active pharmaceutical ingredients 1. Introduction 1.1 Objective 1.2 Regulatory applicability 1.3 Scope 2. Quality management 2.1 Principles 2.2 Responsibilities of the quality unit(s) 2.3 Responsibility for production activities 2.4 Internal audits (self-inspection) 2.5 Product quality review 3 ...
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