ASTM Int'l Committee Approves ASTM E 2474

February 5, 2007 // Published as a news service by IHS

ASTM E 2474 covers process design, which is integral to process development as well as post-development process organization.

In the context of ASTM E 2474, process design refers both to the activities involved in designing a process and the outcome of the activity.

ASTM E 2474 describes practices that should be considered in order to design effective and efficient pharmaceutical manufacturing processes that ensure product quality and performance.

Gerd Fischer, a member of ASTM Committee E55, said that the PAT guidance published by the U.S. Food and Drug Administration (FDA) in 2004 introduces PAT as a regulatory framework that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing and quality assurance.

ASTM E 2474 outlines scientific principles and tools that support process design in a PAT environment and that 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," said 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."

Fischer said that the main users of ASTM E 2474 will be pharmaceutical process developers, manufacturers and quality assurance workers.

Source: ASTM International.