While the continuous quality verification concept is still quite new, it has the potential to become an important approach to assuring product quality in the pharmaceutical industry. With this in mind, ASTM International Committee E55 on Manufacture of Pharmaceutical Products has approved a new standard, E2537, Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing. 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,” says 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 lifecycle, a number of benefits may be afforded, for example, real-time release and continuous quality improvement.”

The purpose of E2537 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. Pharmaceutical manufacturers that have batch or continuous processes that employ analyzers and controllers that monitor, measure, as well as analyze and control the process performance, will be the primary users of the standard.

Interested parties are welcome to participate in future work on E2537, particularly those involved in pharmaceutical and biopharmaceutical manufacturing, research and development and process analytical technologies. “As the industry moves to implementing continuous quality verification, input will be needed again to review and revise the standard based on practical experience,” says Wrigley.

ASTM International standards can be purchased from Customer Service (phone: 610/832-9585; https://www.astm.org/contact/) or at www.astm.org. For further technical information, contact Graham Wrigley, Pfizer Global Manufacturing, Peapack, N.J. (phone: 908/901-8830; graham.wrigley@pfizer.com). Committee E55 meets May 6-8 at the May committee week in Denver, Colo. For membership or meeting information, contact Pat Picariello, Technical Committee Operations, ASTM International (phone: 610/832-9720; ppicarie@astm.org).

Release #7948