On January 12, 2015, the FDA Center for Drug Evaluation and Research (CDER) launched the Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative. The purpose of the OPQ is to establish consistent quality standards for all drugs, whether brand or generic. OPQ will streamline the FDA processes that monitor drug quality throughout the product lifecycle, including drug application review, post-approval changes, and surveillance and inspections of global manufacturing facilities.
OPQ is expected to provide the following support to CDER’s Quality Initiative:
- Enhance quality drug assessment by integrating application review and facility inspection;
- Establish consistent, clinically relevant quality standards and clear expectations for industry;
- Implement a lifecycle approach to quality, spanning pre- and post-approval for both innovator and generic drugs;
- Evaluate risks based on clinically relevant product attributes, which impact the drug safety and efficacy;
- Encourage use of modern, more efficient manufacturing technologies; and
- Focus on robust analytics and surveillance techniques to monitor the state of manufacturing in the pharmaceutical industry.
The new organizational structure, along with new processes and policies should help ensure that safe, effective and high quality drugs are available to the public.