The Pharmaceutical Entrepreneur

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 guarantee that medicines are of the quality required for the use for which they are intended. Quality management therefore integrates good manufacturing practices. Good manufacturing practices apply to stages of the life cycle from manufacturing of investigational drugs technology transfer commercial manufacturing to product discontinuation. However the pharmaceutical quality system can extend to the pharmaceutical development stage which while optional should facilitate innovation and continuous improvement and strengthen the link between pharmaceutical development and manufacturing activities. The size and complexity of the company's activities must be taken into consideration when developing a new pharmaceutical quality system or when the existing one is modified.