Pharmaceutical Microbiology —— Essentials for Quality Assurance and Quality Control

----- 医药微生物学：质量保证和质量控制要点

ISBN: 9780081000229 出版年：2015 页码：318 Sandle, Tim Woodhead Publishing_RM

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.Contains the applications of pharmaceutical microbiology in sterile and non-sterile productsPresents the practical aspects of pharmaceutical microbiology testingProvides contamination control risks and remediation strategies, along with rapid microbiological methodsIncludes bioburden, endotoxin, and specific microbial risksHighlights relevant case studies and risk assessment scenarios