Cleaning validation : Practical compliance approaches for pharmaceutical manufacturing
- Author
- Destin A. LeBlanc
- Publication Year
- 2022
- Publisher
- CRC Press
- Language
- English
- Document Type
- Book
- Faculty / Subject Heading
- Medical Science
- Download Book Read book
Timely coverage of cleaning validation for the pharmaceutical industry, a dynamic area in terms of health-based limits. 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.
Keywords: Pharmacology / Pharmaceutics / Biotechnology / Analysis quality / Pharmaceutical Quality / Pharmaceutical Science Regulatory / Bioscience / Pharmaceutical Science / Quality Assurance / Regulations validation / Standards Validation
