WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 961 - Forty-fifth Report (Geneva, 18–22 October 2010)
(2011; 440 pages)


Annex 1: Release procedure of International Chemical Reference Substances;

Annex 2: WHO good practices for pharmaceutical microbiology laboratories;

Annex 3: WHO good manufacturing practices: main principles for pharmaceutical Products;

Annex 4: WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization);

Annex 5: WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms;

Annex 6: WHO good manufacturing practices for sterile pharmaceutical products;

Annex 7: WHO guidelines on transfer of technology in pharmaceutical manufacturing;

Annex 8: Good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO);

Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization);

Annex 10: Procedure for prequalification of pharmaceutical products;

Annex 11: Guidelines on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities;

Annex 12: Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies;

Annex 13: WHO guidelines for preparing a laboratory information file;

Annex 14: WHO guidelines for drafting a site master file;

Annex 15: Guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format

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