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Environmental and Microbiological Monitoring at Drug Manufacturing Sites
December 16, 2015
Environmental and biological monitoring of drug manufacturing sites gives drugmakers the information they need to comply with FDA and EU regulations on the manufacture of sterile drug products. Monitoring provides critical information on the hygienic status of the sites and thus on the success of cleaning and disinfecting measures. Surfaces, personnel, air, utilities and cleansing agents and disinfectants all have to be tested. Alert and action limits have to be set, as well as measures to be taken if those limits are exceeded.