Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control
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.
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This book is an overview of current approaches to pharmaceutical microbiology, outlining classic methods and rapid microbiology. The central theme is the use of risk assessment, supported by sound scientific principles, to assess product and patient safety.
Antibiotics and preservatives
Cleaning and disinfection
Cleanrooms and environmental monitoring
Rapid microbiological methods
Risk assessment and microbiology
Manufacturing and validation
Auditing the microbiology laboratory