FDA’s Center for Drug Evaluation and Research (CDER) is wrestling with how to reshape its quality regulatory system to foster rather than impede continuous improvement across the lifecycle of a process.
The impediments that the current application/supplement process places on continuous improvement have come into high relief as FDA doubles down on its effort to achieve the vision laid out under its Pharmaceutical Quality for the 21st Century initiative a decade ago of a “maximally efficient, agile, flexible pharmaceutical manufacturing sector that can reliably produce high-quality drugs without extensive regulatory oversight.”
Delivering the keynote speech at the generic drug CMC conference cosponsored by the Generic Pharmaceutical Association (GPhA) and FDA in early June, CDER Director Janet Woodcock reviewed: ● the “historical trajectory of FDA quality regulation” ● where the agency has succeeded and fallen short in realizing its 21st Century vision ● what the obstacles are, and ● what the agency is now doing across the CMC and GMP arenas organizationally and policy-wise to overcome them (see box below).
This historical trajectory has included a continuing increase in the scrutiny of and requirements for manufacturing at both the review and inspection levels. It has entailed ongoing reliance on the pharmacopeias for public standards, which have made progress on but not solved the harmonization problem.
The successes of the 21st Century Initiative have included the introduction of quality by design (QbD), the facilitation of process technology, and the revision and completion of various ICH guidelines including Q8-10, which have advanced the principles of QbD, risk management and quality systems across the international arena.
However, Woodcock stated candidly, “we did not achieve a regulatory system that would enable the vision that we put forth, and we knew that. We knew we had not gotten there. And therefore what we are going to do now is make another attempt to do this.”
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