WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fourteenth Report (WHO Technical Report Series)

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....This is an excellent book with a misleading title... a good reference work for anyone seeking to understand the concept of validation and looking for general guidance on validation for both Active Pharmaceutical Ingredients (API) and finished pharmaceutical products. Annex 5 on Good distribution practices (GDP) for pharmaceutical products is an excellent Annex that splits the task of GDP into 20, small, easy to digest sections that guide the reader through the process of understanding the complexity of controlling distribution of pharmaceutical products. It contains a comprehensive glossary of terms used in GDP... a useful reference book for anyone involved in Quality Assurance, Manufacturing of marketed products, Clinical Manufacturing and Development.- Industrial Pharmacy