FDA’s Quality Beat Goes On

Jan. 13, 2015

In his “From Our Perspective” post January 12, Acting Director of FDA’s Center for Drug Evaluation and Research’s Office of Pharmaceutical Science, Lawrence X. Yu, Ph.D., notes that “When quality issues arise in manufacturing facilities, product recalls and plant shutdowns can follow, often resulting in drug shortages. By far, the most frequently cited reasons – approximately 65 percent – for drug shortages relate to manufacturing and quality issues.” Drug safety and quality hinges on manufacturing excellence and no doubt Yu’s comments were posted on the FDA’s website to support the press conference held the same day announcing the launch of the Center for Drug Evaluation and Research’s (CDER’s) new Office of Pharmaceutical Quality (OPQ).

According to the FDA, the new office creates a drug quality program as robust as the programs the agency has in place for drug safety and efficacy and strengthens its Quality Initiative (see sidebar). Intended to streamline FDA processes that monitor drug quality throughout the product lifecycle, the new office will oversee drug application review, post-approval improvements, as well as surveillance and inspections of global manufacturing facilities.

Yu explains that a primary focus of the effort is to address the quality issues that mainly occur during the manufacture of sterile injectable drug products, issues that range from sterility problems to products contaminated with particles of glass, metal or other materials. Over the past decade, he notes, progress has been made toward quality pharmaceutical manufacturing through the issuance and adoption of the FDA’s International Conference on Harmonization guidances on Process Analytical Technology, Pharmaceutical Development, Quality Risk Management, and Pharmaceutical Quality Systems. “Industry and the FDA have the shared obligation to reduce quality errors and provide high quality medications to the American public.”

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
• Implements risk-based decision-making that balances potential quality risk with availability of quality products to patients.

To fulfill this responsibility, Yu says, both industry and the FDA need to institutionalize a culture of quality. “A true quality culture is an environment in which the entire organization not only follows quality guidelines but also is focused on continuous improvement. It is important to recognize that financial incentives don’t always reduce errors. Employees must be passionate about eliminating mistakes and making quality their driving principle,” explains Yu.

Yu says the creation of the OPQ is focused exclusively on quality. Quality is the foundation for assuring drug performance and should be a key consideration for both regulators and manufacturers at every step of the drug lifecycle. 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.

In the press release announcing the OPQ’s debut, the FDA declared “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.” 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 FDA’s Safety and Innovation Act of 2012 further enhanced CDER’s Quality Initiative by directing FDA to 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,” says the agency “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.”

“Over the years we at FDA have adapted our organizational perspective to proactively deal with the increasing complexity of the industry and its products,” says Yu. The Office of Pharmaceutical Quality ... is one response to the need for a robust regulatory quality oversight program in a changing industrial environment. OPQ intends to be a global benchmark for regulation of pharmaceutical quality.”

The OPQ, says Yu, will strive to achieve the goals laid out in FDA’s 21st Century Quality Initiative by streamlining the drug quality work that is currently being done in multiple parts of our center to provide seamless assessment and surveillance over the product lifecycle. “This new office, says Yu, “will closely integrate review, inspection, surveillance, policy, and research in an effort to provide one unified view on pharmaceutical quality.