Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device and Biotech Industries
Syed Imtiaz Haider
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.
种类:
年:
2001
出版:
1
出版社:
CRC
语言:
english
页:
431
ISBN 10:
1574443313
ISBN 13:
9781574443318
文件:
PDF, 2.04 MB
IPFS:
,
english, 2001