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008 140223b2002 xxu||||| |||| 00| 0 eng d
020 _a9781574443301
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082 _a615.152
_bHAI
100 _aHaider, Syed Imtiaz
245 _aPharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP and GLP
260 _aBoca Raton
_bSt Lucie Press
_c2002
300 _a176p
500 _aPCG00073 PCG00113 This book provides the tools to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD provides a template that can be customized to incorporate additional regulatory requirements specific to individual companies worldwide. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.
600 _aPharmaceutics
890 _aUK
995 _AHAI
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995 _AHAI
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_ZReference
999 _c13756
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