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Cleaning Validation
Practical Compliance Approaches for Pharmaceutical Manufacturing
Angleščina
83 b
Pharmaceutical manufacturers and upper management are encouraged to meet thechallenges 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 amore 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 particularlyupper management, to meet the challenges of the science-based and riskbasedapproaches to cleaning validation. Draws on the author's vast experience in the field of cleaning validationand hazardous materials. Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP forhighly hazardous products in shared facilities. A diverse list of topics from protocol limits for yeasts and molds tocleaning validation for homeopathic drug products.
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