FDA Center for Drug Evaluation and Research (CDER) launched the Office of Pharmaceutical Quality (OPQ) today as part of its ongoing Quality Initiative. This new office creates a drug quality program as robust as the programs 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.

CDER’s Quality Initiative focus:

  • Ensures that patients obtain quality products;
  • Encourages modernization 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 supports CDER’s Quality 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 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.

Quality is the underpinning of everything FDA does to help assure consumers have access to quality medicines, regardless of whether the medications are over-the-counter, prescription, innovator, or generic. Although, it is the company’s responsibility to manufacture safe, effective, high-quality drugs, FDA also plays an important role in helping to assure 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 modernize 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.

The Food and Drug Administration Safety and Innovation Act of 2012 further enhanced CDER’s Quality Initiative by directing FDA to, among other things, improve its risk-based surveillance inspection schedule of manufacturing facilities. To implement this approach, FDA will use performance measures to assess a facility’s quality system to assure product quality. This practice will sharpen FDA’s focus on issues that are critical to quality and create a common language to gauge progress around quality. It will also allow FDA to identify and respond to quality issues at manufacturing facilities before those issues become major, systemic problems.


Posted on the FDA website on 12 January 2015