REGULATORY FOCUS
In December, ASTM’s International Committee E55 on Manufacture of Pharmaceutical Products introduced a standard covering the life cycle of pharmaceutical and biopharmaceutical manufacturing systems. The new standard is E 2500, Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. It falls under the jurisdiction of Subcommittee E55.03 on General Pharmaceutical Standards. According to committee member Sabra Seyer from Pfizer, “packaging systems are included in the scope.”
Seyer reports that “FDA requested that the International Society for Pharmaceutical Engineering (ISPE) team up with ASTM and develop a consensus standard to support a science- and risk-based approach to meet the regulatory requirement to [ensure that] systems are fit for use prior to manufacturing pharmaceutical products.”
ASTM reports that the standard 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.”
New and existing systems are covered in E 2500. “The guide is applicable throughout the life cycle of the manufacturing system, from concept to retirement,” ASTM reports. It allows for “the implementation of changes to current systems as well as their improvement during operation.”
ASTM International standards are available for purchase. Please call 610/832-9585, e-mail service@astm.org, or visit www.astm.org.
ASTM lists Seyer as the contact for technical information. She can be reached at 908/901-8834 or sabra.m.seyer@pfizer.com.
Committee E55 meets May 6-8, 2008, at the May Committee Week in Denver, CO. For membership or meeting information, contact Pat Picariello, Technical Committee Operations, ASTM International at 610/832-9720 or ppicarie@astm.org.
