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Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries. 2nd edition
・ISBN 978-0-8493-9529-1 hard GB£ 290.00
￥91,872.- (税込) ※（※）価格はご注文時の参考価格となります。
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| 著者・編者 | Haider, Syed Imtiaz, |
|---|---|
| 出版社 | (CRC Press Inc, US) |
| 出版年月 | 2006 |
| ページ数 | 1144 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A00-50752＞ |
解説
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.