Cleaning Validation: Practical Compliance Approaches for Pharmaceutical Manufacturing

di Destin A. LeBlanc (Autore)

Taylor & Francis Ltd, 2024

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 pharmaceutical industry, a dynamic area in terms of health-based limits. • The author 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.

• Autore: Destin A. LeBlanc
• Editore: Taylor & Francis Ltd
• Anno: 2024
• Rilegatura: Paperback / softback
• Pagine: 204 p.
• Dimensioni: 229 x 152 mm
• Peso: 400 gr.
• EAN: 9781032431734

Testo in English