Committee E55 on Manufacture of Pharmaceutical Products
Manufacturing Systems Standard Covers Life Cycle of Process
ASTM International Committee E55 on Manufacture of Pharmaceutical Products has developed a new standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard, E 2500, Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, is under the jurisdiction of Subcommittee E55.03 on General Pharmaceutical Standards.
“The U.S. Food and Drug Administration requested that the International Society for Pharmaceutical Engineering team up with ASTM and develop a consensus standard to support a science- and risk-based approach to meet the regulatory requirement to assure that systems are ‘fit for use’ prior to manufacturing pharmaceutical products,” says Sabra Seyer, Pfizer, an E55 member. Pharmaceutical and biopharmaceutical manufacturers will be the primary users of E 2500.
The guide covers all elements of pharmaceutical and biopharmaceutical manufacturing systems including facility and process equipment, supporting utilities, associated process monitoring and control systems and automation systems that can potentially affect product quality and patient safety.
Both new and existing manufacturing systems are covered in E 2500, allowing for the implementation of changes to current systems as well as their improvement during operation. The guide is applicable throughout the life cycle of the manufacturing system, from concept to retirement. In addition, the guide can be applied to laboratory, information and medical device systems as well as pharmaceuticals.
Technical Information: Sabra Seyer, Pfizer, Peapack, N.J.
ASTM Staff: Pat Picariello