Validation of sterile pharmaceutical manufacturing process

Author: (USA) Carleton (Carleton, F.J.), (USA) Agalloco (Agalloco, J.P.)
Publisher:
Publishing Date: 2001-07-01
Features: "Validation of Sterile Pharmaceutical Processes" is a reference book written specifically for managers, administrators, and researchers in the pharmaceutical industry. Its purpose is to provide guidance on validation to design engineers, production and manufacturing personnel, scientists engaged in research and development, and dedicated quality control personnel. It is not only essential for identifying potential obstacles in the initial stages of validation efforts but also for subsequent validation processes. This edition of the book is also intended to meet the needs of the pharmaceutical industry for teaching materials on the validation of sterile pharmaceutical processes, as well as the demand for general reference materials and guidelines. The book integrates various theories, sterilization parameters, and content from engineering and microbiology. These can be used individually or in combination. Do not regard the content and methods provided in this book as "standards" for identifying equipment or validating processes, as standards are mandatory and must be followed. However, these content and methods can be used as guidelines. Other equivalent methods to achieve the same validation objectives exist, and they should be studied and adopted wherever appropriate.