ENGLISH

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical

By Syed Imtiaz Haider

Book information

Publisher
CRC
Year
2001
ISBN
1574443313, 9781574443318
Language
english
Format
PDF
Filesize
2 MB (2213166 bytes)
Edition
1
Pages
496\429
Time added
2012-10-29 21:00:00

Description

A comprehensive when-and-how-to-do-it guide, this book and CD-ROM combination provides administrative solutions for achieving compliance with key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation. The text shows readers how to establish test functions and acceptance criteria in compliance with FDA perspectives. The CD-ROM contains 74 template validation standard operating procedures that users can edit and print, customizing the program to their needs. The book and CD work together to minimize the number of forms used and to ensure that the all the correct forms are used, thus avoiding the stress that usually accompanies an FDA audit.

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