Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control

Provides 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 products

Presents the practical aspects of pharmaceutical microbiology testing

Provides contamination control risks and remediation strategies, along with rapid microbiological methods

Includes bioburden, endotoxin, and specific microbial risks

Highlights relevant case studies and risk assessment scenarios