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