Compliance begins with good design

摘要

To ensure that a life science production cleanroom meets the requirements of EU GMP, Good Manufacturing Practice for Pharmaceutical Manufacturers, compliance should be built in right from the design phase. Various aspects need to be considered during the design process, including process flow, production requirements and validation requirements. The design of the facility needs to be driven by the process requirements, and generation of the process requirements needs a detailed review of the process steps involved in the manufacture and compounding of all the products manufactured in the proposed cleanroom.