Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP and GLP (Record no. 13756)
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000 -LEADER | |
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fixed length control field | 01539nam a2200181Ia 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
fixed length control field | 140223b2002 xxu||||| |||| 00| 0 eng d |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 9781574443301 |
Terms of availability | 0.00 |
082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
Classification number | 615.152 |
Item number | HAI |
100 ## - MAIN ENTRY--PERSONAL NAME | |
Personal name | Haider, Syed Imtiaz |
245 ## - TITLE STATEMENT | |
Title | Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP and GLP |
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
Place of publication, distribution, etc. | Boca Raton |
Name of publisher, distributor, etc. | St Lucie Press |
Date of publication, distribution, etc. | 2002 |
300 ## - PHYSICAL DESCRIPTION | |
Extent | 176p |
500 ## - GENERAL NOTE | |
General note | 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. |
600 ## - SUBJECT ADDED ENTRY--PERSONAL NAME | |
Personal name | Pharmaceutics |
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995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
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995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
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