Sterile Drug Products

Sterile Drug Products: Formulation Packaging Manufacturing and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions suspensions ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades to over 3000 participants and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms be it product development (formulation package process analytical) manufacturing quality control quality assurance regulatory purchasing or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools providing basic knowledge and principles in four main areas of parenteral science and technology: Product development including formulation packaging and process development. Manufacturing including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory including the application of good manufacturing practice regulations aseptic processing guidelines and unique quality control testing methods for the sterile dosage form Clinical aspects including administration potential hazards and biopharmaceutics of sterile products in a clinical setting. . Language: English