Cleaning Validation (eBook)

Practical Compliance Approaches for Pharmaceutical Manufacturing

Destin A. LeBlanc (Autor)

eBook Download: PDF

2022
216 Seiten
CRC Press (Verlag)
978-1-000-83559-5 (ISBN)

Infos

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.

Produkt-Details

• Erscheint lt. Verlag: 23.12.2022
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Gesundheitsfachberufe
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie
• Themenwelt: Naturwissenschaften ► Biologie
• Themenwelt: Technik ► Umwelttechnik / Biotechnologie
• ISBN-10: 1-000-83559-6 / 1000835596
• ISBN-13: 978-1-000-83559-5 / 9781000835595