Pharmaceutical Equipment Validation

Phil Cloud

Detalles del libro
Editorial: CRC Press
ISBN: 1-57491-079-5
ISBN-13: 9781574910797
Materia: Libros de Farmacologia
Comprehensively covering equipment qualification and process validation for pharmaceutical process equipment, this text shows readers how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. The author delineates how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst-case scenario. The thirty-eight completed protocol templates cover specific equipment types, provide instant answers to most protocol writing and testing questions, show how to qualify each piece of equipment, and provide a check for readers' own protocols.