This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.
Author(s): World Health Organization
Series: WHO Technical Report Series 40
Publisher: World Health Organization
Year: 2006
Language: English
Commentary: 58212
Pages: 478
Preliminaries......Page 1
Contents......Page 5
1 Introduction......Page 13
2 General Policy......Page 14
3 Quality control specifi cations and tests......Page 18
5 Quality control national laboratories......Page 21
6 Quality assurance Good Manufacturing Practices......Page 22
9 Quality assurance risk analysis......Page 23
11 Prequalifi cation......Page 24
12 Regulatory guidance on interchangeability for multisource generic pharmaceutical products......Page 25
15 Nomenclature and computerized systems......Page 27
16 Summary and recommendations......Page 28
at the next meeting of the Expert Committee......Page 30
Acknowledgements......Page 33
List of available International Chemical Reference Substances and International Infrared Reference Spectra......Page 47
Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms......Page 57
Supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines......Page 97
Supplementary guidelines on good manufacturing practices validation......Page 119
Good distribution practices for pharmaceutical products......Page 191
A model quality assurance system for procurement agencies......Page 217
Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability......Page 359
Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms......Page 403
Additional guidance for organizations performing in vivo bioequivalence studies......Page 451
