Posts tagged New Facility Validation
Validation Master Planning for a State of The Art Sterile Manufacturing Facility

Problem Definition

A large pharmaceutical conglomerate was establishing a brand new, state of the art sterile manufacturing plant.  The facility design had to comply with the requirements of the United States Food and Drug Administration (FDA), the Japanese Ministry of Health and Welfare (JMHW) and the European Agency for the Evaluation of Medical Products (EMEA).  However, the effort had the following major stumbling blocks....

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