WHO Expert Committee on Sqecifications for Pharmaceutical Preparations

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WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS

1. Introduction 1
2. General policy 6
3. Joint session with the Expert Committee on Biological Standardization 13
4. Quality control – specifi cations and tests 14
5. Quality control – international reference materials (International Chemical Reference Substances and International Infrared Reference Spectra) 28
6. Quality control – national laboratories 31
7. Quality assurance – good manufacturing practices 33
8. Quality Assurance – new approaches 35
9. Quality assurance – distribution and trade of pharmaceuticals 36
10. Prequalifi cation of priority essential medicines 39
11. Prequalifi cation of quality control laboratories 41
12. Prequalifi cation of active pharmaceutical ingredients 44
13. Regulatory guidance 44
14. Nomenclature, terminology and databases 48
15. Summary and recommendations 51
Acknowledgements 58
Annex 1
Release procedure of International Chemical Reference Substances 67
Annex 2
WHO good practices for pharmaceutical microbiology laboratories 69
Annex 3
WHO good manufacturing practices: main principles for pharmaceutical products 94
Annex 4
WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization) 148
Annex 5
WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms 215
Annex 6
WHO good manufacturing practices for sterile pharmaceutical products 261
Annex 7
WHO guidelines on transfer of technology in pharmaceutical manufacturing 285
Annex 8
Good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO) 310
Annex 9
Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization) 324
Annex 10
Procedure for prequalifi cation of pharmaceutical products 373
Annex 11
Guidelines on submission of documentation for prequalifi cation of innovator finished pharmaceutical products approved by stringent regulatory authorities 391
Annex 12
Prequalifi cation of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies 393
Annex 13
WHO guidelines for preparing a laboratory information fi le 403
Annex 14
WHO guidelines for drafting a site master fi le 409
Annex 15
Guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format 417