While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough...
While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide ...
Explains in detail how to develop and manage qualification protocols and their associated documentation for all of the validation department functions Shows how to perform qualification testing and establish a requalification program Describes how various documents relate to each other and to an overall documentation system Discusses in details key function areas, such as Cleaning, Facilities and Utilities, Equipment, Computers and Software, and Process Provides ready-to-use protocols and protocol templates All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good...
Explains in detail how to develop and manage qualification protocols and their associated documentation for all of the validation department functions...
