Destin A. LeBlanc
Cleaning Validation
Practical Compliance Approaches for Pharmaceutical Manufacturing
Gebonden Engels 2022 1e druk 9781032430836
Verwachte levertijd ongeveer 11 werkdagen
Samenvatting
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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