Pharmaceutical, Medical

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the By Syed Imtiaz Haider
Publisher: CRC
Number Of Pages: 496
Publication Date: 2001-12-27
Sales Rank: 966674
ISBN / ASIN: 1574443313
EAN: 9781574443318
Binding: Hardcover
Manufacturer: CRC
Studio: CRC
Average Rating: 1

Book 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.