ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has approved its first practice. ASTM E 2474, Practice for Pharmaceutical Process Design Utilizing Processing Analytical Technology, is under the jurisdiction of Subcommittee E55.02 on PAT System Implementation and Practice.

Practice E 2474 covers process design, which is integral to process development as well as post-development process organization. In the context of E 2474, process design refers both to the activities involved in designing a process and the outcome of the activity. E 2474 describes practices that should be considered to design effective and efficient pharmaceutical manufacturing processes that ensure product quality and performance.

Gerd Fischer, member of Committee E55 and director, industrial quality and compliance, Sanofi-Aventis, says that the Process Analytical Technology guidance published by the U.S. Food and Drug Administration in 2004 introduces PAT as a regulatory framework that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing and quality assurance. E 2474 outlines scientific principles and tools that support process design in a PAT environment, and that are suitable to facilitate innovation and risk-based decisions.

“E 2474 will help to focus process design and development on science- and risk-based design strategies to manage variation,” says Fischer. “Integration of PAT principles and tools during process design will enhance opportunities to build, maintain and expand science- and risk-based process understanding throughout a product’s life cycle.”

Because process design is such an important part of the development process, as well as post-development process optimization, Fischer notes that the main users of E 2474 will be pharmaceutical process developers, manufacturers and quality assurance workers.

CONTACT:

Technical Information: Gerd Fischer
Sanofi-Aventis, Frankfurt, Germany
Phone: +49 69 305 17932

ASTM staff: Pat Picariello
Phone: 610/832-9720

Upcoming Meeting: May 22-24
May Committee Week
Norfolk, Va.