Farmaceutisk kemi og teknologi
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Cleaning Validation
Practical Compliance Approaches for Pharmaceutical Manufacturing
Udgivet af Taylor & Francis Ltd
ISBN
9781032430836
Om denne bog
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…
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Bogdetaljer
Forfatter
Destin A. LeBlanc
Forlag
Taylor & Francis Ltd
Kategori
Farmaceutisk kemi og teknologi
ISBN-13
9781032430836
EAN
9781032430836
Format
Indbundet
Sprog
Engelsk
sider
204
Undertitel
- Practical Compliance Approaches for Pharmaceutical Manufacturing
Produktbeskrivelse
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 authors 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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