On October 23rd, ISPE LA held a program about Applying ASTM E2500.
Phil Bowles, Director of Engineering at Amgen Inc., talked about the journey towards a fully mature risk-based approach for commissioning and qualification of equipment and facilities.
Mr. Bowles spoke about the industry’s risk-based approach based on the ASTM E2500 Guide. He explained that ASTM E2500 is a Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. It provides a science (ICH Q8) and risk (ICH Q9) based approach to assure that GMP equipment & systems are fit for use, perform satisfactorily, and may be used in the manufacturing, processing, packaging, and storage of a drug. It applies the concept of critical quality attributes and calls for the use of subject matter experts (SMEs) to make critical determinations, and redefines roles for Quality and Technical SMEs. It allows flexibility so that the company determines the methodology.