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Cleaning Validation: Practical Compliance Approaches for Pharmaceutical Manufacturing.
・ISBN 978-1-032-43083-6 hard GB£ 83.99
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| 著者・編者 | LeBlanc, Destin A., |
|---|---|
| 出版社 | (CRC Press, UK) |
| 出版年月 | 2022 |
| ページ数 | 204 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A01-65143＞ |
解説
Pharmaceutical manufacturers and upper management are encouraged to meet the
challenges of the science-based and risk-based approaches to cleaning validation.
Using some of the principles and practices in this volume will help in designing a
more effective and efficient cleaning validation program.
Features
* Timely coverage of cleaning validation for the pharmaceutical industry,
a dynamic area in terms of health-based limits.
* The author encourages pharmaceutical manufacturers, and particularly
upper management, to meet the challenges of the science-based and riskbased
approaches to cleaning validation.
* Draws on the author's vast experience in the field of cleaning validation
and hazardous materials.
* Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for
highly hazardous products in shared facilities.
* A diverse list of topics from protocol limits for yeasts and molds to
cleaning validation for homeopathic drug products.