Mitigating Producer Risk in a Highly Regulated Environment
Byron PR, Christopher J, Falco B, Vanneste C.
Respiratory Drug Delivery 2006. Volume 1, 2006: 159-168.
Abstract:
The chemistry, manufacture, and control (CMC) of orally inhaled and nasal drug products (OINDP), continues to be a focus of regulatory debate. FDA requirements of NDA sponsors of new inhalers have, for some time, been the most exacting in the world. While few debate the need for improved inhalers, or high quality drug delivery systems of any kind, deciding how to achieve this goal requires that (a) we agree on what constitutes “high quality” and (b) we use appropriate incentives and disincentives to promote quality-enhancing change in the products on the market. While FDA’s most recent initiative (to move NDA reviews to “a new risk-based pharmaceutical quality assessment system”) is intended to stimulate improvements in product quality, it is unclear whether this largely CMC initiative will stimulate improvements in clinically discernable safety and efficacy, or exactly how the review process will be affected for OINDP. All modifications in CMC requirements bring with them an inevitable “producer risk” of failed batches, for statistical reasons, when some such batches actually possess comparable quality to those found to be safe and efficacious in clinical trials. As CMC requirements for OINDP continue to change, producer risk of unwarranted batch failures may also increase, often inadvertently. Aspects of this topic will be discussed from statistical, regulatory and practical product development viewpoints.
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