Pharmaceutical Products Committee Approves ASTM Int'l Standard - ASTM E 2500
December 16, 2007 // Published as a news service by IHS
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products developed a standard that covers the life cycle of pharmaceutical and biopharmaceutical manufacturing systems.
ASTM E 2500 - Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment 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.
"The U.S. Food and Drug Administration and International Society for Pharmaceutical Engineering teamed up with ASTM to develop a consensus standard to support a science- and risk-based approach to meet the regulatory requirement to assure systems are 'fit for use' prior to manufacturing pharmaceutical products," said Sabra Seyer, Pfizer, an E55 member.
Both new and existing manufacturing systems are covered in ASTM E 2500, which allows for the implementation of changes to current systems as well as their improvement during operation, said ASTM International.
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, said ASTM International.
Pharmaceutical and biopharmaceutical manufacturers will be the primary users of ASTM E 2500.
ASTM E 2500 is under the jurisdiction of Subcommittee E55.03 on General Pharmaceutical Standards.
Source: ASTM International.