ENGLISH

Validation of Pharmaceutical Processes - Sterile Products

By Carleton

Book information

Publisher
Informa Healthcare
Year
1998
ISBN
9780824793845, 0824793846
ASIN
1
LCC
RS199.S73 V345 1999
Open Library ID
OL382371M
Language
english
Format
RAR
Filesize
28 MB (28873031 bytes)
Edition
2
Pages
818\0
Topic
Chemistry\\Pharmacology
Library
Kingdwarf
Time added
2010-01-07 06:59:20

Description

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.

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