FDA Center for Drug Evaluation and Research strengthens its quality initiative

The US FDA's Center for Drug Evaluation and Research (CDER) has launched the Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative.

The regulator says this new office creates a drug quality programme 'as robust as the programmes the Agency already has in place for drug safety and efficacy'.

OPQ will streamline FDA processes that monitor drug quality throughout the product lifecycle, including drug application review, post-approval improvements, and surveillance and inspections of global manufacturing facilities.

The CDER’s Quality Initiative ensures that patients obtain quality products; encourages modernisation of drug manufacturing; establishes clear standards for review and inspection and clear enforcement policies; establishes patient-focused, clinically relevant specifications for quality; and implements risk-based decision-making that balances potential quality risk with availability of quality products to patients.

OPQ will support CDER’s initiative by providing a means to:

• 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 have an impact on 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 FDA says quality underpins everything that it does to help ensure that consumers have access to quality medicines, regardless of whether they are over-the-counter, prescription, innovator, or generic.

Although it is the company’s responsibility to manufacture safe, effective, high-quality drugs, the FDA also plays an important role in helping to ensure that quality products reach patients by establishing and enforcing appropriate quality standards.

CDER’s Quality Initiative began more than a decade ago when the agency first introduced the 21st Century Initiative to modernise the FDA’s regulation of the pharmaceutical quality of drugs. The initiative included issues related to product quality, with current good manufacturing practices as important tools for improving overall product quality.