Publisher: Woodhead Publishing
Year of Publication: 2015
Author(s) : Tim Sandle
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, bio burden, toxins, microbial identification, culture media, and contamination control.
Ref : http://store.elsevier.com/Pharmaceutical-Microbiology/Tim-Sandle/isbn-9780081000229/