A Look Ahead at Manufacturing and Regulation - Pharmaceutical Technology

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A Look Ahead at Manufacturing and Regulation
FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, overall approaches.


Pharmaceutical Technology Europe


Drug-manufacturing quality

PTE: In August 2011, FDA released a strategic plan, Advancing Regulatory Science at FDA. Priority 3 of that plan focuses on product manufacturing and quality, including enabling the development and evaluation of novel and improved manufacturing methods to improve product quality, namely through continuous manufacturing, novel manufacturing technologies, excipients and complex dosage forms, and process analytical technology (PAT) and quality-by-design (QbD) approaches. What does FDA and the industry hope to gain by focusing on these areas?

FDA: FDA is responsible for protecting the consumer through the availability of quality products. These approaches focus on good, sound science in achieving a high quality product. By applying QbD and understanding the role of excipients and complex dosage forms, a higher level of product and process understanding will be obtained. The other approaches, (PAT, continuous manufacturing and novel manufacturing technologies) utilise that understanding to achieve a more robust and capable manufacturing processes, resulting in higher product quality. With this higher level of product quality, the product failure rate is expected to drop, which in turn, will increase product availability, and reduce product cost. Therefore, by focusing on these science-based approaches, FDA is confident that the overall quality of pharmaceutical products [will] continue to increase.

Modernising manufacturing approaches for pharmaceuticals, such as through QbD, continuous manufacturing and/or PAT, has the potential to benefit industry, regulators, and patients. Already, there have been multiple reports of quality and cost benefits to manufacturers through the use of QbD and/or PAT approaches. For patients, these approaches can lead to increased assurance of quality and product availability. For regulators, it potentially means less regulatory oversight postapproval due to regulatory flexibility (e.g., design space) filed with the application. FDA is currently pursuing additional pathways to ease postapproval changes for well-understood and controlled processes under a robust quality system.

Continuous manufacturing, although new to most pharmaceutical manufacturing, is a commonly used technology in food and chemical processing. As more companies are gaining experience with continuous manufacturing, benefits are emerging, including cases of reduced manufacturing scale-up issues, reduced material usage in development, and flexible manufacturing capacities. Because of the changing dynamics of new drugs toward more specialised, lower-volume products, continuous manufacturing could become more commonplace in the years ahead.

Finally, it is becoming increasingly important to understand the interactions between drug(s), excipients, and device components as pharmaceutical dosage forms are becoming more complex, such as multiple active ingredients in a single drug product or drug–device combinations. The higher level of understanding should allow for more robust products that deliver their intended performance when either planned or unplanned changes are introduced.

Analytical methods

PTE: Priority 3 in the strategic plan also calls for developing new analytical methods, including those to determine 'similarity' between reference products and biosimilars as well as tools to detect physical properties of complex dosage forms. What gains are hoped for amongst agency scientists in these analytical areas?

FDA: Advances in analytical methods to determine 'similarity' between reference products and biosimilars, as well as tools to detect physical properties of complex dosage forms, will allow for greater confidence that there are no structural differences between products or that any differences observed are minor. For biosimilars, this will reduce uncertainty and allow for a targeted development program. This can also facilitate the development and approval of generics with complex dosage forms, as well as inform control strategies for quality of complex originator products.


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