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Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP and GLP

By: Material type: TextTextPublication details: Boca Raton St Lucie Press 2002Description: 176pISBN:
  • 9781574443301
Subject(s): DDC classification:
  • 615.152 HAI
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Holdings
Item type Current library Item location Collection Call number Status Date due Barcode Item holds
Reference Book Reference Book NIMA Knowledge Centre 6th Floor Silence Zone Reference 615.152 HAI (Browse shelf(Opens below)) Not For Loan P0003992
Book Book NIMA Knowledge Centre 9th Floor Reading Zone General 615.152 HAI (Browse shelf(Opens below)) Available P0002269
Total holds: 0

PCG00073 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.

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