Quality assurance of pharmaceuticals: a compendium of guidelines and related materials: volume 2: Good manufacturing practices and inspection, 10th ed

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials: volume 2: Good manufacturing practices and inspection, 10th ed

This publication guides the manufacturing and quality control of pharmaceuticals, vaccines and other biologicals, and other medical products to ensure their quality, safety, and efficacy.

The importance of GMP cannot be overstated. High-quality medical products are essential for the prevention and treatment of diseases and for improving the overall health and well-being of all people of all ages without leaving anyone behind. Poorquality products, on the other hand, can lead to adverse effects, treatment failure, and even death. The recent deaths of children in The Gambia, Indonesia and Uzbekistan due to contamination of cough syrups should not be allowed to happen again because these are preventable deaths.

The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.