ASTM Int'l Releases Pharmaceutical Verification Standard - ASTM E 2537
April 3, 2008 // Published as a news service by IHS
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products approved ASTM E 2537 - Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing.
The purpose of ASTM E 2537 is to address the application of continuous quality verification to those manufacturing processes that employ modern quality management systems often supplemented with modern process analytical chemistry systems and controls, according to ASTM International.
The standard is under the jurisdiction of Subcommittee E55.03 on General Pharmaceutical Standards.
"Continuous quality verification is an alternative process validation approach whereby the desired quality attributes are ensured through continuous assessment during manufacture," said Graham Wrigley, E55 member and senior manager, PGM Global Quality Operations Center, Pfizer Inc.
"The adoption of this quality approach will move us from the documentation of a discreet process validation exercise to a science-based systematic approach. With the knowledge obtained during the product life cycle, a number of benefits may be afforded, for example, real-time release and continuous quality improvement."
Pharmaceutical manufacturers that have batch or continuous processes that employ analyzers and controllers that monitor, measure, analyze and control the process performance will be the primary users of the standard.
Parties involved in pharmaceutical and biopharmaceutical manufacturing, research and development and process analytical technologies are invited to participate in future work on ASTM E 2537.
Source: ASTM International.