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94 World Health OrganizationWHO Technical Report Series, No. 961, 2011 Annex 3 WHO good manufacturing practices for pharmaceutical products: main principlesIntroductionGeneral considerationsGlossaryQuality management in the medicines industry: philosophy and essential elements1. Quality assuranceProduct quality review2. good manufacturing practices for pharmaceutical products3. Sanitation and hygiene4. Qualifi cation and validation5. Complaints6. Product recalls7. Contract production and analysisGeneralThe contract giver The contract accepter The contract8. Self-inspection, quality audits and supplier s audits and approval Items for self-inspection Self-inspection team Frequency of self-inspection Self-inspection report Follow-up action Quality audit Suppliers audits and approval9.
96 Introduction The fi rst WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth
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