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

Syed Imtiaz Haider0849395291, 9780849395291

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

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Table of contents :
Front Cover……Page 1
CONTENTS……Page 6
PREFACE……Page 12
THE AUTHOR……Page 20
ABOUT THE BOOK……Page 22
INTRODUCTION……Page 26
VAL 100.00……Page 28
VAL 200.00……Page 34
VAL 300.00……Page 120
VAL 400.00……Page 142
VAL 500.00……Page 162
VAL 600.00……Page 176
VAL 700.00……Page 284
VAL 800.00……Page 362
VAL 900.00……Page 398
VAL 1000.00……Page 442
VAL 1100.00……Page 460
VAL 1200.00……Page 486
VAL 1300.00……Page 492
VAL 1400.00……Page 502
VAL 1500.00……Page 568
VAL 1600.00……Page 644
VAL 1700.00……Page 712
VAL 1800.00……Page 894
VAL 1900.00……Page 968
VAL 2000.00……Page 1006
VAL 2100.00……Page 1014
VAL 2200.00……Page 1070
VAL 2300.00……Page 1140