Essentials for quality assurance and quality control Sandle, Tim creator text uk Cambridge, UK Waltham, MA (USA) Elsevier 2016 Elsevier 2016 monographic spa

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xii, 298 p. : figures, tables. Introduction to pharmaceutical microbiology -- Microbiology and pharmaceuticals -- GMP and regulations -- Laboratory management and design --Microbiological culture media -- Microbiology laboratory techniques -- Bioburden determination -- Specified and objectionable microorganisms -- Microbial identification -- Assessment of pharmaceutical water systems -- Endotoxin and pyrogen testing -- Sterilization and sterility assurance -- Biological indicators -- Antibiotics and preservatives -- Cleaning and disinfection -- Cleanrooms and environmental monitoring -- Rapid microbiological methods -- Risk assessment and microbiology -- Manufacturing and validation -- Microbiological data -- Auditing the microbiology laboratory -- Microbiological challenges too the pharmaceuticals and healthcare. Tim Sandle. References at the end of each chapter. MICROBIOLOGIA FARMACEUTICA FARMACOLOGIA 615.19 S217 9780081000229 (print) 9780081000441 (online) clsautm 260923 20260928094809.0 40991