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February 6, 2023
By: Emil W. Ciurczak
Independent Pharmaceuticals Professional
When I was part of the US-FDS PAT sub-committee in 2002, Dr. Ajaz Hussain (FDA) brought in people from industries that were using in-process controls (e.g., the automotive industry) to run workshops, using their experience to address “stress-points” in “normal” GMP manufacturing. It was quite informative and helped form the basis of the FDA Guidances and ICH (International Conference on Harmonization) Q8, 9, 10, 11, etc. I was invited largely because of my work using NIRS for incoming raw material qualification, implemented at Sandoz in 1984. My only point of dispute with Dr. Hussain was his suggestion to shut down an entire process line, upgrade each step with validated monitors, then validate the whole system on a product-by-product basis. Now, when you buy your first home, unless you were born into money, you start small and, as the family and your income(s) grow, you can move upward in size and cost. My suggestion was to pick a “low-hanging fruit” project, such as blend uniformity—first performed by Pfizer in late 1980s—or drying, both already using NIR monitors at some early-initiator companies. So, when you show management that your first project 1) works and 2) can be validated, and 3) it speeds up production and minimizes waste, and 4) and most important to the “bean-counters,” it saves money, allowing for a larger profit. Then, and only then, you can ask for funds to add other monitors along the process stream, slowly building to a full PAT/QbD process line. In other words, you don’t have to buy/build all the monitors before you begin gathering PAT experience, it can be done gradually. Likewise, a company does not (normally) spend millions of dollars/euros for a full-sized, fully automated, Continuous Manufacturing (CM) suite. Just as we have numerous and efficient contract research organizations (CROs), there are a number of locations in the U.S. and Europe where they perform contract PAT/QbD R&D and a number that can generated a continuous manufacturing protocol for you. Figure 1 below shows a small unit at the U. of Eastern Finland, used to perform contract PAT/QbD development.
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