Preliminaries -- Contents -- 1 Introduction -- 2 General Policy -- 3 Quality control specifi cations and tests -- 4 Quality control International Reference Materials -- 5 Quality control national laboratories -- 6 Quality assurance Good Manufacturing Practices -- 7 Quality assurance inspection -- 8 Quality assurance distribution -- 9 Quality assurance risk analysis -- 10 Quality assurance stability -- 11 Prequalifi cation -- 12 Regulatory guidance on interchangeability for multisource generic pharmaceutical products -- 13 Donations of medicines -- 14 Regulatory guidance on post approval changes -- 15 Nomenclature and computerized systems -- 16 Summary and recommendations -- at the next meeting of the Expert Committee -- Acknowledgements -- List of available International Chemical Reference Substances and International Infrared Reference Spectra -- Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms -- Supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines -- Supplementary guidelines on good manufacturing practices validation -- Good distribution practices for pharmaceutical products -- A model quality assurance system for procurement agencies -- Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability -- Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms -- Additional guidance for organizations performing in vivo bioequivalence studies.