Making dissolution testing and the Biopharmaceutics Classification System (BCS) it supports more meaningful is high on the agenda of the Office of Pharmaceutical Quality (OPQ) as it works with the Product Quality Research Institute (PQRI) to advance the quality regulatory process.
Dissolution testing and the BCS were among the pressing issues receiving attention at a conference on “Advancing Product Quality,” cosponsored by FDA and PQRI in October in Bethesda, Maryland.
Industry and agency presentations and subsequent discussion in a breakout session on biopharmaceutics and BCS biowaivers focused on: ● the roadblocks to the use of biowaivers ● scientific advances in the area of in vivo predictive dissolution testing, and ● the need for international harmonization on classification and required testing in the biopharmaceutics arena.
Indicative of its importance, biowaiver policy is among the top three agenda items for the International Generic Drug Regulatory Program (IGDRP) as it works to harmonize generic drug technical and regulatory requirements and promote convergence among its participating countries around the world.
The October FDA/PQRI conference was the second of what will be an annual series held to bring representatives from regulatory agencies, industry, and academia together to exchange viewpoints and collaborate on the front burner issues in quality regulation.
OPQ was actively involved in setting the agenda for the conference, and a broad swath of its management and staff gave presentations and/or participated in the discussions.
The conference had four parallel tracks focused on:
● Emerging regulatory initiatives, including biopharmaceutics and BCS biowaivers, the ICH Q12 guidance on pharmaceutical product lifecycle management, dissolution testing, quality metrics, and botanical drug development and quality standards
● Regulatory submission, assessment, and inspection, including breakthrough therapy CMC challenges, pre-approval and surveillance inspection, risk-based regulatory assessment, pharmaceutical quality systems, and FDA integrated quality assessment
● Product and process development, including formulations containing nanomaterials, biosimilar products, palatability and swallowability, content uniformity, and scale-up, and
● Manufacturing, risk management, and quality assurance, including data integrity, continuous manufacturing, process capability, and identification and control of critical quality attributes and critical process parameters.
Summaries of the discussions at each of the sessions in the tracks were provided by the moderators on the third morning of the conference.
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