000			nam a22 4500
999			_c6149 _d6149
005			20191126170547.0
008			181019b xxu||||| |||| 00| 0 eng d
020			_a1574910795
040			_cAIKTC-KRRC
041			_aENG
082			_2DDC23 _a615.19 _bCLO
100			_94764 _aCloud, Phil
245			_aPharmaceutical equipment validation _b: The ultimate qualification guidebook
260			_aNew York _bInforma Healthcare _c2007
300			_av, 443p. _bHard Bound
520			_aWhile 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 understanding of 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. _bNo other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.
650		0	_94765 _aPHARMACEUTICAL ANALYSIS
942			_2ddc _cBK