Cover -- Contents -- WHO Expert Committee on Specifications for Pharmaceutical Preparations -- 1. Introduction -- 2. General policy -- 2.1 Cross-cutting pharmaceutical quality assurance issues -- 2.1.1 Update from the Expert Committee on the Selection and Use of Essential Medicines -- 2.1.2 Update from the Expert Committee on Biological Standardization -- 2.1.3 Temperature mapping of a storage area -- 2.2 International collaboration -- 2.2.1 Collaboration with international organizations and agencies -- 2.2.2 Pharmacopoeial Discussion Group -- 2.2.3 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) -- 2.2.4 International Conference of Drug Regulatory Authorities -- 3. Quality control - specifications and tests -- 3.1 The International Pharmacopoeia -- 3.1.1 Monographs under elaboration -- 3.1.2 Monographs proposed for elaboration or withdrawal from The International Pharmacopoeia -- 3.2 Specifications for medicines, including children's medicines -- 3.2.1 Maternal, newborn, child and adolescent health medicines -- 3.2.2 Antimalarial medicines -- 3.2.3 Antiviral medicines -- 3.2.4 Antituberculosis medicines -- 3.2.5 Medicines for neglected tropical diseases -- 3.2.6 Other anti-infective medicines -- 3.2.7 Other medicines -- 3.3 General monographs for dosage forms and associated method texts -- 3.3.1 Supplementary information -- 3.3.2 Reagents, test solutions and volumetric solutions -- 3.3.3 General policy -- 3.3.4 Radiopharmaceuticals -- 4. Quality control - International Reference Materials (International Chemical Reference Substances and Infrared Reference Spectra) -- 4.1 Update on International Chemical Reference Substances -- 4.1.1 Overview -- 4.1.2 Release procedure for International Chemical Reference Substances -- 4.1.3 Report from the ICRS Board.

4.1.4 Draft chapter on reference substances and reference spectra for the Supplementary information section of The International Pharmacopoeia -- 4.1.5 International Chemical Reference Substances - miscellaneous topics -- 4.2 Report of the custodian centre for ICRS -- 4.2.1 Annual report -- 4.2.2 Update on the annual report -- 5. Quality control - national laboratories -- 5.1 External Quality Assurance Assessment Scheme -- 5.1.1 Final report on EQAAS 5.6 -- 5.1.2 Preliminary report on EQAAS 5.7 -- 5.1.3 EQAAS Phase 6 proposals -- 5.2 Networking -- 5.3 Training materials for quality control laboratories and microbiological laboratories -- 6. Quality assurance - good manufacturing practices -- 6.1 Updates of WHO good manufacturing practices -- 6.2 Update of WHO good manufacturing practices: validation -- 6.3 General guidance for inspectors on "hold-time" studies -- 6.4 Training materials -- 7. Quality assurance - new initiatives -- 7.1 International meetings of world pharmacopoeias -- 7.2 Good pharmacopoeial practices -- 7.3 FIP-WHO technical guidelines -- 7.4 Screening technologies for "suspect" medicines -- 7.5 Laboratory functions survey regarding testing of spurious/falsely-labelled/falsified/counterfeit medical products -- 8. Quality assurance - distribution and trade of pharmaceuticals -- 8.1 WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce -- 8.1.1 Update -- 8.1.2 Proposed letter to Member States -- 8.2 Monitoring and surveillance of the national supply chain -- 8.2.1 Project update -- 8.2.2 Proposal for a procedure on sampling and market surveillance survey -- 8.3 Proposal for revision of good trade and distribution practices for starting materials -- 8.3.1 Good trade and distribution practices for pharmaceutical starting materials -- 8.4 Procurement agencies.

8.4.1 Model quality assurance system for procurement agencies -- 8.4.2 Assessment tool for procurement agencies -- 8.4.3 Product questionnaire -- 9. Prequalification of priority essential medicines -- 9.1 Update on the Prequalification Programme managed by WHO -- 9.1.1 Progress report -- 9.2 Revision of guidelines for prequalification of finished pharmaceutical products approved by stringent regulatory authorities -- 9.2.1 Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities -- 10. Prequalification of active pharmaceutical ingredients -- 10.1 Update on the prequalification of active pharmaceutical ingredients -- 11. Prequalification of quality control laboratories -- 11.1 Update on the prequalification of quality control laboratories -- 11.2 Update on WHO quality monitoring projects -- 12. Regulatory guidance -- 12.1 Pharmacovigilance and "quality defect" reporting -- 12.2 Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part -- 12.3 Proposal for general guidance on variations -- 12.4 Guidelines on registration requirements to establish interchangeability (bioequivalence) -- 12.5 Update of biowaiver list based on the WHO Model List of essential medicines -- 12.6 Update of International Comparator Products List and related guidance on selection of comparator products for equivalence assessment of interchangeable multisource (generic) products -- 13. Nomenclature, terminology and databases -- 13.1 Quality assurance terminology -- 13.2 International Nonproprietary Names for pharmaceutical substances -- 14. Miscellaneous -- 14.1 Strategy -- 14.1.1 References -- 15. Summary and recommendations -- Acknowledgements.

Annex 1 The International Pharmacopoeia - Updating mechanism for the section on radiopharmaceuticals -- Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles -- Annex 3 Model quality assurance system for procurement agencies -- Annex 4 Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection -- Annex 5 Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities -- Annex 6 Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.