Drug Quality at Center Stage for FDA and Manufacturers - Pharmaceutical Technology

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PharmTech Europe

Drug Quality at Center Stage for FDA and Manufacturers
Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.

Pharmaceutical Technology
Volume 37, Issue 1

Regulatory changes

The potential impact of quality manufacturing systems on innovation and drug access provides a strong platform for change in quality regulation, says Woodcock. CDER's pharmaceutical quality initiatives have yielded many successes, as seen in expanded online monitoring of production lines; development of software and other technology to monitor manufacturing processes and detect errors; harmonisation of quality risk-management concepts through the International Conference on Harmonisation; and implementation of QbD approaches at many companies.

FDA has been less productive with efforts to provide industry with relief on manufacturing supplements and to build a pharmaceutical inspectorate with greater expertise for evaluating innovative quality production systems. Woodcock is hopeful that added resources provided by the Generic Drug User Fee Act (GDUFA) will revive the inspectorate program and provide more parity between foreign and domestic site visits.

CDER also is responding to these developments by establishing an Office of Pharmaceutical Quality (OPQ), another "super office" that will coordinate the review of chemistry, manufacture and controls (CMC) data in applications with compliance efforts to ensure adherence to good GMPs at plant sites. OPQ will replace the Office of Pharmaceutical Science (OPS), whose long-time director, Helen Winkle, is retiring from the agency.

This change will bring together all CMC reviewers for generic drugs, conventional drugs and biologics. In addition, the Office of Manufacturing and Product Quality (OMPQ) in CDER's Office of Compliance will join the new entity. Meanwhile, the Office of Generic Drugs (OGD) is becoming a separate CDER super office and will operate more like CDER's Office of New Drugs, with responsibility for reviewing bioequivalence, microbiology and clinical data and clearing product labels. More details about the reorganisation and OPQ should emerge over the next six months.

The regulations for CMC submissions and GMPs cover much of the same territory, so it makes sense to bring together the staff members that evaluate them, commented Jon Clark, OPS associate director for regulatory policy, at the IQ symposium. One advantage of the new structure is that it will encourage discussion of GMPs much earlier in the development process and hopefully avoid the kinds of production delays that could stymie market approval. The appointment of Howard Sklamberg, deputy associate commissioner for regulatory affairs, to head CDER's compliance office also brings in someone highly familiar with FDA's field force operations to help shape new inspection models.

Woodcock is hopeful that this reorganisation and other initiatives will promote better ways to ensure drug quality, while also encouraging innovation. The current system for monitoring manufacturing activities is highly resource intensive, yet it fails to direct oversight to higher risk situations. "We're not just moving boxes," she insists, but looking to focus more on data surveillance and metrics, instead of site inspections, to provide faster review of applications plus improved procedures for ensuring quality manufacturing around the world.

Jill Wechsler is Pharmaceutical Technology Europe's Washington editor, Tel: +1 301 656 4634,


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