Frequently Asked Questions about CDER’s Quality Initiative and Office of Pharmaceutical Quality
Q: I have an original application for a new drug or biological product, and with the launch of the Office of Pharmaceutical Quality (OPQ) I’m not certain who I should contact with questions about my application.
Your contact will remain the same.
Q: Did CDER launch OPQ because quality concerns at pharmaceutical companies around the globe are on the rise?
No. While we’ve seen quality issues, we have not seen increased quality issues across the board. Our goal is to work proactively to prevent quality issues from occurring and to help mitigate them before quality issues result in drug shortages.
Q: How will OPQ impact quality pharmaceutical manufacturing in the United States and around the world?
Our goal is to work proactively with the pharmaceutical industry to prevent quality issues from occurring and help mitigate them before quality issues result in drug shortages. FDA will continue to work to assure quality medicines are available for the American public by balancing potential quality risks with availability of quality products to patients.
Q: Will OPQ help FDA identify problem manufacturing facilities more quickly? If so, how will the office work with CDER’s Office of Compliance and FDA’s Office of Regulatory Affairs (ORA) to resolve these issues before enforcement action is needed?
OPQ will integrate and streamline all quality functions (review and inspection) within CDER. OPQ will use its surveillance capabilities, information such as quality metrics, and improved data management to identify product areas or manufacturing facilities with potential quality risks. OPQ will work closely with ORA to prioritize inspections for such products and facilities to try to mitigate quality problems before they lead to a recall or the need for enforcement action. CDER’s Office of Compliance and OPQ, in conjunction with ORA, are also working to streamline processes related to inspection and enforcement. For more information, see FDA’s Program Alignment Addresses New Regulatory Challenges.
Q: Did FDA establish OPQ to streamline its internal processes, or is the real goal to do more enforcement on quality issues?
FDA established OPQ to improve our internal assessment of drug quality and facilitate interactions with industry to improve drug product quality by encouraging modernization of manufacturing technologies and using proactive, collaborative approaches to identify and mitigate quality issues before they lead to drug shortages or recalls.
- Enhance quality drug assessment by integrating quality review and inspection.OPQ will integrate review of drug applications with the evaluation of manufacturing facilities, leading to a single, more informed quality assessment. This assessment will follow a team-based approach, whereby experts in each area of drug development and manufacturing work closely with field investigators, which will improve the evaluation of drug quality at the time of product approval. Internal customers at FDA, such as the Office of New Drugs and the Office of Generic Drugs, will receive a single, integrated quality assessment that captures the overall OPQ recommendation on approvability.
- Establish consistent quality standards and clear expectations for industry. Safeguarding the clinical performance of a drug requires establishing consistent, scientifically sound, and clinically relevant quality standards. Product standards should be captured in critical quality attributes and clinically relevant specifications. Identifying quality problems, requiring corrective actions where standards are not met, and making enforcement decisions will require close interaction among OPQ, the Office of Compliance, and the Office of Regulatory Affairs.
- Anticipate quality problems before they develop and help prevent drug shortages. Anticipating and mitigating quality problems are critical for protecting and promoting public health and giving health care professionals confidence in the quality of drugs they prescribe. Most often, production disruptions leading to drug shortages are the result of failures of product quality or the facility itself. With better knowledge of product and facility quality, we can help assure better quality drugs that are consistently available.
- Use quantitative metrics to help monitor quality. One aspect of FDA’s quality initiative is to enhance FDA’s ability to monitor quality across facilities by using quantitative quality metrics. This information will help identify establishments that may be more likely to encounter quality failures—possibly leading to a drug shortage—and establishments that are consistently operating under control. It will also help to prioritize FDA inspections.
Q: What does FDA mean by a “lifecycle approach to quality”?
OPQ’s Office of Lifecycle Drug Products will evaluate post-approval changes to innovator drugs, as well as original abbreviated new drug applications for generic drugs, which means that knowledge about quality issues gained from review of the innovator product can be appropriately applied to the review of the generic product.
OPQ will systematically document risks to quality associated with an innovator drug and how those risks were addressed during the innovator drug approval process. This information will enable OPQ reviewers to assess post-approval changes to approved innovator or generic drugs.
Q: Are FDA’s current good manufacturing practices (CGMPs) outdated and will OPQ work to revitalize the manufacturing standards?
FDA’s CGMP regulations are not outdated. CGMPs require that industry continually improve drug quality by incorporating technological changes, process knowledge gained during commercial manufacturing, and information from clinical experience. Many pharmaceutical manufacturers already implement comprehensive, modern quality systems and risk management approaches that exceed the basic CGMP requirements.
FDA frequently publishes guidances for industry and staff to communicate the agency’s current thinking on how firms should carry out the requirements of the CGMP regulations. These guidance documents help industry understand how FDA expects manufacturers to build quality into manufacturing processes in order to produce safe, effective, and high-quality products for patients.
OPQ’s Office of Policy for Pharmaceutical Quality (OPPQ) will work with various CDER and FDA-wide organizations to continue developing and implementing CGMP policy for human drugs.
Q: How is this different than FDA’s 21st Century Initiative on the Regulation of Pharmaceutical Manufacturing, from the early 2000s?
FDA introduced its 21st Century Initiative in 2002 to modernize FDA’s regulation of pharmaceutical quality of drugs. The initiative includes issues related to product quality, with current good manufacturing practices being an important tool for improving overall product quality.
FDA and industry made great strides with the 21st Century Initiative program. However, we realized through the 21st Century Initiative that not only did industry need to make some changes, but FDA also needed to change and improve. In many ways, the launch of OPQ can be thought of as the 21st Century Initiative 2.0.
Q: What is the difference between the Office of Compliance’s role and the Office of Pharmaceutical Quality’s role when it comes to quality?
The Office of Compliance (OC) focuses on compliance and enforcement operations and policy, and OPQ focuses on non-enforcement-related drug quality activities. OPQ’s and OC’s approaches are complementary, recognizing that enforcement strategies and actions must focus on quality and be patient-centered and risk-based. OC’s revised structure supports development of enforcement policies and standards that are integrated with OPQ’s approaches for review, surveillance, and policy.
Q: Is OPQ tied to the reorganized Office of Generic Drugs?
CDER’s Office of Generic Drugs reorganized in 2014 and was pulled out of CDER’s former Office of Pharmaceutical Science (OPS). The remaining OPS staff are now part of OPQ. OPQ will continue to work with OGD and OND on all drug applications.