To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. More than 75 relevant international guidelines, standards and good practices endorsed by the Committee are reproduced in this volume, providing guidance covering all aspects of medicines quality assurance throughout the life-cycle of a medicine, from its development to the supply to the patient.

This new 2015 edition includes:
* Revised procedure for the development of monographs and other texts for The International Pharmacopoeia
* Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia
* Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: nonsterile process validation
* New: General guidance for inspectors on hold-time studies
* New: 16 Technical supplements: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products
* Revised Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients
* Revised Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
* Revised Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
* New: Good review practices: guidelines for national and regional regulatory authorities

This CD-ROM also includes a study pack with a huge set of training materials reflecting the various GXP texts, good practices for manufacturing and quality control.