Inside E55: Task Groups Go Tête-à-Tête in Toronto

By Gawayne Mahboubian-Jones, Director of Engineering, Optimal Industrial Automation Gawayne Mahboubian-Jones is also the ASTM E55 Committee's Recording Secretary. ASTM E55, the committee responsible for writing standards to support the Food and Drug Administration's Process Analytical Technology (PAT) initiative, formally meets twice a year, typically in May and November, although creating and voting on standards continues throughout the year. May’s meeting this year was held in Toronto and was composed of seven sections spread over three and a half days. These included: The opening day was billed as a series of introductory presentations to ensure all the attendees were ‘up-to-speed’ with the objectives and work of E55. This will happen at all meetings for the foreseeable future because the membership is growing rapidly, so new members are constantly becoming involved. The highlight was Helen Winkle’s talk, which focused on FDA’s commitment to the standards-making process (even recognizing that there would be difficulties). She also issued a challenge to E55 to broaden its scope to include all pharmaceutical standards. The second day comprised meetings of most of the task groups. The meetings were not sequential, so individual prioritization was essential. In the Process Design task group, all the remaining issues were dealt with and the current document was put forward for final. This document provides an excellent high-level view of the components required to ensure that PAT processes are adequately designed. The document is now moving forward to the final stages of approval and it is hoped that it will be published in late summer. The Risk Assessment task group has also made important progress. This work item covers the application of risk assessment to PAT processes and some of its components are already being widely used in explaining the underlying principles of PAT. Significant revisions and improvements to the document were