IQPC’s Philly Conference Focuses on ROI, Management Issues

By Emil W. Ciurczak, Chief Technical Officer, Cadrai Group

PharmaManufacturing.com

Emil Ciurczak reviews December’s conference, which broke with tradition by focusing more on the business than the technical side of PAT.

Editor's Note: The following is Emil Ciurczak's first-hand, first-person review of IQPC's PAT Business Strategies Summit, which was held Dec. 5-7 in Philadelphia, Pa.

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Normally, I do not attend all sessions on every day of a meeting (of any kind). I would like to state that this one was a rare exception. I have been associated with PAT since I was a member of the PAT sub-committee for the FDA. Most pre- and post-guidance meetings have been concerned with the actual measurements, hardware, and software. As such, the majority of the audience has been scientifically trained (chemists and engineers). Unfortunately, scientists and engineers don’t write the checks in an organization.

This PAT meeting was a break with tradition: a syllabus mostly concerned with the economic and personnel requirements of PAT. The format was a little different from many meetings I have attended over the years, so I will be using a somewhat different outline from my usual reports. I cannot describe in detail all the sessions and talks, so I will relate some highlights of the program (and hope not to offend speakers not mentioned, but, there were soooo many good talks…)

Day 1

The first day consisted of three workshops:

1. Quantitative Process Characterization: a First and Important Step of a Successful PAT Program,
   
   
2. Developing Manufacturing Excellence Through the Implementation of PAT, and
   
   
3. Perceived Barriers and Facilitators to PAT Adoption.

Philippe Cini (Tunnell Consulting) ran the first. His emphasis was on the hardware and software used in PAT. The group went through two exercises where they applied Process Characterization Methodology to products. These tools included various statistical programs, control charts, multivariate analyses, screening and optimization DOEs (Design of Experiments). Thus, the thrust was where to place the instruments for maximum information, not just data.

The group used these tools to analyze manufacturing problems and characterize key drivers of variation in a control release drug product. The brainstorming was a classic demonstration of using various disciplines (a staple of PAT) to attack a multilayered problem. The groups presented their solutions after a suitable conferencing period. The dual purposes were to show the value of differing views and the sheer number of approaches that could be considered.

The second session was run by Gary Ritchie (USP), who was a last-minute substitute (but you would never know it from the finished product). Gary used the FDA guidance on PAT as the framework of the interactive session. Adding the work being performed by the ASTM E55 committee on process control, the lively session was a model of participation. Gary stressed communication; communication within an organization and constant communication with the FDA. Basically, the FDA does not work well with surprises. It is far better to work on PAT with them from day one.

The third workshop, chaired by Nancy Mathis (Mathis Instruments) had the students/participants brainstorming factors which (they believed) will aid or impede implementation of PAT in a company. It was interesting that some participants placed some agents in both columns. The results of this session were the “kickoff” for the second day’s talks. The most interesting point was how participants viewed Quality Assurance and/or the FDA as potential aids or barriers to PAT.

Day 2

I had the pleasure of chairing this day’s session, so was able to interact and ask questions freely. Indeed, seldom have so many people wished to ask questions or comment on the content of talks. Fortunately, breaks were one-half hour and the crowd was small enough to mingle at the group lunches. Few questions were left unanswered.

As I mentioned under Day 1, Nancy Mathis began Day 2 by moderating a panel consisting of PAT experts from GSK, Wyeth, (late of) Aventis, Invensys and Patheon. There were similarities between their experiences and different outlooks, as well. [Since there were no recording devices to encourage candid remarks, I will not attribute quotes to any one member of the panel.]

One point of consensus was that all levels of the company had to be on board for any PAT project to succeed. It was agreed that QA had to be included in the preliminary discussions or they would be the biggest defender of the status quo. Since the mission of QA is to keep the company from violating protocol, it is understandable that a QA kept from the project will, on principle, oppose changes in current practices.

It was interesting to see that the member from Puerto Rico believed that (for critical products) the goal is 100% analysis of dosage forms. The others, while not openly disagreeing, were not pushing the point. All did agree that there were “antibodies” within any organization. That is, ANY new idea will have some person who will attempt to block it. Careful planning, proper personnel (include ALL departments), and thoughtful arguments against the “nay-sayers” are needed to go forward. All agreed that a knowledgeable “champion” within the company, of at least vice-president level, is the key to pursuing the dream of PAT. The least successful approach is to have PAT arise from any single department, then try to sell the concept to all the other interested parties.

Other speakers addressed concepts not normally stated openly. Jean-Marie Geoffroy (GPO Manufacturing Sciences), in addition to encouraging us to build the business case, made another important point: PAT can reduce the oversight opportunities of the FDA. In other words, showing control allows the Agency to visit other sites where the “old ways” still hold sway. That was a different concept: more control by the company means less control by the Agency.