Editor's Note: 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.
Mays meeting this year was held in Toronto and was composed of seven sections spread over three and a half days. These included:
- An opening workshop which was addressed by Helen Winkle, Director of OPS in the FDA (see "Be Patient, Says Winkle: PAT Standards Development Will Take Time");
- A set of task group meetings concentrating on various individual documents;
- Sequential meetings for each of the four major sub-committees;
- A meeting of the full committee.
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 Winkles talk, which focused on FDAs 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.
Process design document due late summer
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 agreed upon, and a new draft will be balloted in the next few months.
Multi-Variate Analysis (MVA) is a component of PAT that has not been widely used by the process side of the pharmaceutical industry in the past. The draft produced by this task group is a valuable set of "practices" which guides users in the appropriate implementation of MVA. Detailed discussion on some of the sections resulted in modifications, but it is expected that a revised draft will be submitted soon and it is hoped that this can serve as the basis of a formal publication.
Three more general work items were also addressed. Using equipment calibration to remove the need for dissolution calibrator tablets is a subject that has generated significant interest (both positive and negative). No task group meeting on this subject took place in Toronto, because a draft was out for ballot, but the subject was a regular talking point in the extensive informal discussions that take place at such an event. The next stage is a meeting of interested parties during the 3rd quarter, with a view to submitting a revised draft before the November meeting.
The second and third items seek to improve the efficiency of validation and qualification, while still ensuring quality standards. One looks at a science and risk-based approach to qualification that would streamline existing approaches, the other examines Continuous Quality Verification (that is, using the output of the process to continuously verify that it is running correctly). These items are exciting wide interest, not least because of the potential for efficiency improvements, but they will require significant work to meet the exacting standards required by the regulators.
Other subjects covered in task group meetings included Process Understanding, Fitness for Use, Qualification of PAT Controls, Thermal Effusivity, PAT Data Management and Process Capability.
Developing a common language
A meeting of three of the four sub-committees dealt primarily will reports of project status, but the fourth sub-committee Terminology performs a vital task in our diverse community: It ensures that a common vocabulary exists across the membership. This is a not insignificant task for E55, whose members are drawn from a wide range of disciplines, and often have very different ways of looking at issues.
Nevertheless, the sub-committee already has well over 50 terms defined and published, with another 30 under consideration and at least 50 more due to come in from the task groups. The terminology document forms an important resource, not just for E55, but for the entire PAT community, because recent conferences have clearly demonstrated that we are not yet speaking a common language.
Finally, the main committee, having completed its basic administrative work, spent a valuable few hours looking to the future development of standards for PAT, seeking a way to prioritize industry needs. To the credit of the committee, this view has matured significantly over the 30 months of E55's existence, and the view is now that the framework documents are the most important. Thus, work items you might expect to see appearing in the near future include: "Control Strategies", "Design Space", "Real-Time Release", and "Model-Based Predictive Control".
Add your voice to the chorus
As a closing comment, E55 benefits from the involvement of practitioners from North America and Europe (who account for more than 30% of all members), but it is always true that in a consensus standards environment, more is better.
Membership is inexpensive ($75 per year) and gives you access to all the working drafts, as well as the opportunity to have your voice heard in the debate through the balloting procedure.
Consider joining! (Click here for details.) The next full meeting is in November 2006 in Copenhagen, Denmark, and E55 is using the European venue as a springboard to seek greater involvement from European regulators.
There has also been an invitation to hold a future meeting in Japan. We hope that E55 is at the beginning of a process that will help to create truly international standards for the pharmaceutical industry.
