Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, this practical guide covers methods and technologies required by regulatory authorities throughout the world. Focused on compliance with the European Pharmacopeia and related regulations, the calibration of laboratory equipment, hygiene procedures, ambient monitoring, and the validation of standard microbiological methods is described in detail, usually with step-by-step protocols.
Pharmacopoieal as well as non-pharmacopoeial methods for the identification and quantification of microorganisms are discussed, including cell culture tests, selected animal test, as well as rapid methods. Dedicated chapters cover microbiological water examination and the potential for automation of standard tests. This practice-oriented refrence is an all-in-one resource for successfully setting up and running a microbiologcal quality control unit in the pharmaceuticals, diagnostics, and cosmetics industry.