Le Labo High Tech: Strategic Guide to Good Manufacturing Practices for Generic Drugs

Quality management is a broad concept that covers everything that can, individually or collectively, influence the quality of a product. It represents all the measures taken to ensure that medicinal products are of the required quality for their intended use. Quality management therefore integrates good manufacturing practices. Good manufacturing practices apply to all stages of the life cycle, from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing, and product discontinuation. The size and complexity of the company's activities must be taken into consideration when developing a new pharmaceutical quality system or when modifying an existing one. The system design must incorporate appropriate risk management principles, including the use of appropriate tools.