ASTM Int'l Establishes New Subcommittee on Pharmaceutical Standards

February 2, 2006

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ASTM International Committee E55 on Pharmaceutical Application of Process Analytical Technology (PAT) created a new subcommittee, E55.03 on General Pharmaceutical Standards, which will address issues of 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.

Subjects to be addressed include measurement and sampling systems, general quality issues (for example, calibration, validation and continuous verification), general control topics and other aspects of pharmaceutical quality.

The chair of the new subcommittee is David Radspinner, PAT business development director, Thermo Electron Corporation. Radspinner said that the subcommittee will focus on guides at first and gradually work toward developing practices and test methods.

"Committee E55 was formed to encourage the growth and adoption of process analytical technology practices within the pharmaceutical community," said 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 accelerating the innovation and adoption of PAT, according to Radspinner.

Source: ASTM International.