Cleaning Validation

清洁验证:药品生产的实用符合性方法

生物工程

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作      者
出  版 社
出版时间
2023年01月26日
装      帧
精装
ISBN
9781032430836
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页      码
204
开      本
229 x 152 mm (6 x 9)
语      种
英文
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图书简介
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 phamaceutical industry, 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
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