New ASTM Subcommittee Focuses on General PAT Standards

ASTM International’s (West Conshohocken, PA, www.astm.org) Committee E55 on Pharmaceutical Application of Process Analytical Technology has established a subcommittee, “E55.03 on General Pharmaceutical Standards,” to focus on issues relating to quality within a chemistry, manufacturing, and control framework.

"Committee E55 was formed to encourage the growth and adoption of process analytical technology practices within the pharmaceutical community," says David Radspinner, PAT business development director for Thermo Electron Corporation (Waltham, MA, www.thermo.com)  and chairman of the new subcommitee. "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.

E55.03 standards will address topics such as measurement and sampling systems, general quality issues (e.g., calibration, validation and continuous verification), general control topics and other aspects of pharmaceutical quality. Radspinner says that the subcommittee will first focus on guides and gradually work toward developing practices and test methods.

"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."