Categorized | Opinion Editorial, QbD News

IFPAC 2012: The Club Opens Up

    IFPAC 2012: The Club Opens Up

    by Agnes Shanley

    Our contributing editor Emil Ciurczak will be posting the “official” reports on IFPAC next week, but here is an informal and irreverent look at the conference for those who couldn’t be there. IFPAC 2012 was notably different this year. Attendance was up by double digits, according to director Bob Zutkis, and there were plenty of people from QC and operations at the sessions. I’ve been covering this conference for a few years now. It used to be a bit like the “PAT club” (later the “PAT and QbD club”), a place where those who know about process control, analytics and industrial engineering could get together and lament that they were such a minority in pharma. “If only the majority would understand how much smarter all this is,” they seemed to say, again and again (…and again). There was something almost wistful about it.

    Three-Letter Acronyms On Their Way Out?
    Well, if this conference is any indication, maybe that club’s opening up, more people are starting to see the benefit of modern control, and the  three-letter acronyms are disappearing, but taking on new forms,  PAT morphing into smarter process validation and QbD, into process knowledge.

    And wasn’t that the goal anyway?

    Instead of jetting off right after his talk, the person responsible for bringing the PAT acronym to pharma, the former FDA PAT Team Leader who shall remain nameless, was able to stay for a while at the conference this year. He was optimistic about the industry’s uptake of PAT and QbD.  “I knew it was going to take some time,” he said.

    His former cohort, consultant Ali Afnan, gave several strong (and entertaining) presentations on the topic of process control. He used his favorite car analogies to bring the points home, and showed why he was such an eloquent spokesman for PAT while at FDA.  Instead of sitting quietly during some of the sessions, he openly challenged some speakers, citing military sampling standards, for instance, during a session on QC sampling (more on that separately in a more serious post).

    He also came out with what was possibly the best quip of Day 1, pointing to fellow boffin Gawayne Mahboubian Jones, now with cigarette and aspiring vaccine producer Phillip Morris, and asking the audience, “He works for a company that creates cancer in people at a Six Sigma level. Why is it that our industry can only cure it at Two Sigma?”

    Theodora Kourti was a dynamic presence, Emil Ciurczak questioned and commented insightfully, but he brought real laughter to the rather sedate crowd on Day 2 (ok, what he said wasn’t all that racy, but I guess I can’t repeat it in case it might offend any extremely religious readers).

    Here are just a few of many interesting presentations:  one from Vertex on preformulation work, using G3D Raman. Raman mapping, NIR and other methods to study excipient-API interactions in granules during preformulation–smart example of QbD in action, there was a look at Merck’s IT platform, which enables its use of PAT/QbD, we heard about the excipient database program that FDA is funding at NIPTE, and best practices from Pfizer. Among many brilliant young presenters, a standout was Fani Boukouvala from Rutgers, who talked about a dynamic flowsheet simulation her team, led by Fernando Muzzio (another major presence at the conference) for continuous manufacturing.

    FDA’s Rick Friedman spoke on risk assessment, and had some very memorable things to say on the topic of sampling, and the need to connect pharmaceutical manufacturing measurements back to the patient.

    In short, it was a good show and suggests that more people in the industry are open to positive change, and good old fashioned process control.

    Related posts:

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    3. IFPAC Reflections Day Two: From Models to Multivariate Stats
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    2 Responses to “IFPAC 2012: The Club Opens Up”

    1. siegfried says:

      It is still beyond comprehension why none of the presentations from this conference are made available at all. The organissers’ excuse is too lame to repeat here.

    2. epcotint says:

      Siegfried:

      Answer is simple. The presentation did not meet the cGMP requirements and had to be recalled before they got to the press. Presentation had too many TLA’s (three letter acronyms) that were not properly documented and/or approved by the regulatory bodies or too risqué to be published.

      As Agnes has said that “Club” was opening but it was realized that too many “unwanted” had come in. They had to rationalize and simplify using statistical and mathematical analysis techniques. The model became so complex that computer started saying “cannot rationalize and beyond comprehension”.

      I just could not resist. Life will rationalize one of these days. Cheers.

      Girish Malhotra

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