ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology has created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues on quality within a broad framework of chemistry, manufacturing and control.

The scope of the new subcommittee is the development of general principles, practices and related standards for managing quality in the pharmaceutical industry. The chair of the new subcommittee is David Radspinner, PAT business development director, Thermo Electron Corporation. Russell Madsen, Williamsburg Group, is vice-chair and Bruce Davis, AstraZeneca, will be secretary.

"Committee E55 was formed to encourage the growth and adoption of process analytical technology practices within the pharmaceutical community," say Radspinner. "Other subcommittees have focused on PAT-specific standards, but there was recognition that broader standards on pharmaceutical quality were needed to enable the PAT standards." The broader standards developed by E55.03 will apply to areas beyond PAT, while at the same time accelerating the innovation and adoption of PAT, according to Radspinner.

The entire pharmaceutical community, including developers, manufacturers, testing laboratories, regulatory bodies and academia, will be able to use standards developed within Subcommittee E55.03. Radspinner believes that, given the subject matter of the subcommittee, it will attract a broad range of stakeholders.

"As with other E55 subcommittees, we are seeking interested parties who bring innovative ideas, experience and knowledge of pharmaceutical quality to this effort," says Radspinner. "We invite all interested parties to come forward with proposed work items for guides, practices, test methods, specifications or terminology or to participate in existing work items."

Subjects to be addressed in E55.03 standards will include measurement and sampling systems, general quality issues (for example, calibration, validation and continuous verification), general control topics and other aspects of pharmaceutical quality. Radspinner says that the subcommittee will focus on guides at first and gradually work toward developing practices and test methods.

"The establishment of Subcommittee E55.03 provides a valuable venue to further discuss standards relevant to process understanding and control, the basis for all work within Committee E55," says Donald Marlowe, United States Food and Drug Administration and chair, Committee E55. "I envision that the standards developed by E55 will play a critical role in the regulation of pharmaceutical product and process quality."

For further technical information, contact David Radspinner, Thermo Electron Corporation, Madison, Wis. (phone: 608/276-5604; david.radspinner@thermo.com). Committee E55 will meet May 16-18, at the May Committee Week in Toronto, Ontario, Canada. For membership or meeting details, contact Pat Picariello, ASTM International (phone: 610/832-9720; ppicarie@astm.org).

Release #7322