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New Process Analytical Technology Committee Approves First Standard

ASTM’s recently formed Committee E55 on Pharmaceutical Application of Process Analytical Technology has developed and approved its first standard, ASTM E 2363, Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry. The standard, which includes definitions for 41 terms, has been envisioned as the first step in the standardization of process analytical technology as applied in the pharmaceutical industry.

According to Lawrence Hecker, senior consultant, Hospira, and chair of Subcommittee E55.91 on Terminology, E 2363 will be useful because of its content, but also because it represents the first truly consensus standard developed with the full participation of industry, academia, and the U.S. Food and Drug Administration Center for Drugs and Experimental Research. “This standard is truly an international effort with representatives from several European and Asian countries participating,” says Hecker. “We hope that this initial effort will lead to a series of standards that better define and control the way pharmaceutical active ingredients and finished dosage forms are manufactured.” Hecker feels that the collaboration that has occurred between industry and government during the development of E 2363 will result in benefits for both, as well as for the public through the manufacture of better quality, more cost-effective drugs.

Now that E 2363 has been approved, E 55 has other types of standards under development, particularly test methods and management standards. All interested parties are invited to participate in the development of these standards, as well as in future revisions to E 2363. According to Hecker, “The development of standards such as E 2363 and the ones under development should not only help improve product quality and cost, but also help lead to the development of new and innovative technologies that will assure the continued advancement of the science and art of pharmaceutical manufacturing while helping to maintain a consistency of product around the world.”

For further technical information, contact Lawrence Hecker, Hospira, Inc., Lake Forest, Ill. (phone: 224/212-4657). Committee E55 meets Nov. 10-11 during the November Committee Week in Washington, D.C. For membership or meeting details, contact Pat Picariello, ASTM International (phone: 610/832-9720). //

Copyright 2004, ASTM International