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题名/责任者:

Cleaning validation : practical compliance approaches for pharmaceutical manufacturing / Destin A. LeBlanc, Consulatant, Cleaning Validation Technologies.

版本说明:

First edition.

出版发行项:

Boca Raton, FL : CRC Press, 2023.

ISBN:

9781032430836

ISBN:

1032430834

ISBN:

9781032431734

ISBN:

1032431733

载体形态项:

xi, 203 pages : illustrations ; 24 cm

个人责任者:

LeBlanc, Destin A., author.

论题主题:

Sterilization.

论题主题:

Cleaning.

论题主题:

Pharmaceutical technology-Quality control.

中图法分类号:

R954

书目附注:

Includes bibliographical references and index.

摘要附注:

"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. Timely coverage of cleaning validation for the pharmaceutical industry is a dynamic area in terms of health-based limits. Author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and risk-based 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. Diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products"--

豆瓣简介：