Therapeutic Dose: How I was Shanghaied (and Surprised)

Watch out. Asian pharma professionals are serious about learning how to do PAT and QbD

By Emil Ciurczak, Contributing Editor

Recently I was given the opportunity to visit Singapore and Shanghai to attend a PAT/QbD conference, give two workshops, and present two papers. Both the conference and the workshops were sponsored by IBC-Asia (an Informa Company). And, since I had worked with the European branch (London), they contacted me to participate over there. I had to fight Hurricane Sandy to get my visa from the New York-based Chinese consulate, but it was well worth the effort.

I expected Singapore to be modern, considering the fact that over one-sixth of the people living there are millionaires. It was amazing and, of course, quite spotless (a several-hundred dollar fine for littering helps).

To my happy surprise, virtually everyone spoke English (officially, Malay is the primary language, but the English influence lingers).

I was very pleasantly surprised at how big (23 million people) and modern so much of Shanghai was. I’m not sure about you readers, but we seem to have a slightly outdated view of the large cities in China. [For anyone interested, I have pictures.]

I only mention the vast building and infrastructure explosion to frame my happy surprise at the sincere interest in the concepts of PAT and QbD. There is a desire to become a modern country and, it would appear, making world-class drug products comes along with that desire. I don’t pretend that the country is fully up to date, but they seem determined to get there. Now what was I doing there?

My workshop topics were the ICH Q8, Q9, Q10, and Q11 Guidances, the Validation Guidance, as well as general PAT and QbD; my two talks were on the financial impact of PAT and building a multidisciplinary Quality Unit. I had no idea ahead of time how the topics would be received by a new audience at a new venue. I shouldn’t have worried; before I even left Singapore for Shanghai, I had gotten several emails asking for my slides. In all, I was contacted by attendees from India, Shanghai and Singapore. One even sent me a paper he had published where he used PAT for API production and was looking for ideas to expand to dosage form production.

Among comments I received were, “You tied all the pieces together; now we know what these mean,” and “I wasn’t aware that so much was involved.” While chatting with the various workshop students and conference attendees, it was obvious that the companies that sent them are serious and wish to get away from the image that the many recalls and tainted products have created in our minds about Asian Pharma companies. While the vast majority of the people there worked for generic companies, they were interested in making quality products.

The very fact that I had a student from the Validation Group of her company shows that they were serious...the fact that they HAD a Validation Group surprised me. The companies in attendance ranged from Merck (Germany) to companies whose names I couldn’t attempt to pronounce (and was told they were fairly small). They were attentive (but, then I am old and am told the Chinese respect age...more so than my own kids, but I digress) and asked quite a number of questions (once I convinced them they were allowed to interrupt).

They took copious notes (which, being in Chinese, I couldn’t understand) and asked for sources for more information. While Facebook is not allowed in China, the Internet is pretty open (if monitored, as was stated in my hotel sign-on page) and they have the ability to search most of what I spoke about. I explained that the USFDA site was a gold mine of information as they had rules that all presentations were posted. I got funny looks when I tried to explain “sunshine laws,” but finally made the point.

After spending some time with the students, I began to understand some of their difficulties with the Guidances. For one, even to a native-English speaker, the formal Guidances are sometimes difficult to read and grasp all the fine points. In a country where English is seldom spoken (except to sell things in the neat marketplaces), courses similar to mine are seen as a service. Instructors (I’m nowhere near the only one giving workshops) who read, digest, and make Guidances into logical diagrams and bullet-points are performing a service to developing countries, I believe.

Based on how quickly the Asian production sectors have grown and grabbed a market share from the West, I would be wary of their ability to master the concepts of PAT and QbD. In other words, unless we stop dragging our feet and jump into the 21st Century, these fast growing economies are going to eat our collective lunches. (And, don’t forget Brazil, India and Eastern Europe, among others…) It’s no time to be complacent.

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