Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions
The FDA’s CDER Metrics program is set to launch early next year. Although this initiative is voluntary in 2018, it signals a new direction for how the FDA will approach future compliance and inspection practices. A risk-based, data-driven approach will become key to ongoing compliance and success. It’s important to understand and prepare for the upcoming CDER Metrics initiative even if you’re not yet ready to participate.
Pharmaceutical Quality and Continuous Improvement
Continuous improvement and innovation in the pharmaceutical manufacturing industry are an important part of the FDA’s mission to protect and promote public health. Industry currently uses quality metrics to drive improvement and monitor quality systems and processes. Therefore, the FDA released a draft guidance “Submission of Quality Metrics Data Guidance for Industry” in November 2016 to address these quality issues.
This new reporting program will help the FDA segment and support high performers, address product shortage issues, and advance operational excellence and quality practices. It is expected that most of the quality metrics data will be collected and evaluated by manufacturers as part of their ongoing monitoring programs.
How Will the FDA Use Quality Metrics Data?
The FDA envisions that information collected from a fully implemented quality metrics reporting program will be important in focusing the use of FDA resources on the areas of highest risk to public health. Activities include:
- establishing a signal detection program to identify establishments and products that may pose significant risk;
- identifying situations in which there may be a risk for drug supply disruption;
- improving the effectiveness of establishment inspections; and
- improving the FDA’s evaluation of drug manufacturing and control operations.
The metrics described in the guidance do not strictly determine the quality of the establishment or its products. Therefore, the FDA intends to use quality metrics information with other knowledge available to them in order to achieve these goals.
The CDER Metrics Program is Voluntary…for Now
The CDER quality metrics program is voluntary during 2018. This voluntary phase will allow the FDA to use information about participating establishments in its risk-based decision making as the agency further develops the quality metrics reporting program. It will also allow all types of drug manufacturing establishments to report information.
Note that the FDA does not intend to take enforcement action based on errors in a quality metrics data submission made during this voluntary phase, provided that the submission is made in good faith.
Participation in the voluntary phase shows commitment to increasing transparency between industry and the FDA, and contributes to improved quality monitoring. Use of the information generated in this phase may be limited if the FDA does not receive a large body of data, as it may not be representative of the industry. The FDA does not intend to publicly disclose information submitted during the program’s voluntary phase since that is considered confidential commercial information under the Freedom of Information Act.
It’s All in the Numbers
In the November 2016 “Submission of Quality Metrics Data“, the FDA identifies the scope of the data it will collect. These include three metrics to monitor Lot Acceptance Rate, Product Complaint Rate, and Invalidated OOS (Out of Specification) Rate. The FDA maintains that these metrics will enable it to evaluate the quality culture of the firm.
Learn More in Our Upcoming Webinar
Although the metrics – and the data surrounding them – can be daunting, there’s no need to be frightened by CDER Metrics. On October 31st, Pilgrim will present a live webinar with information and solutions to calm your fears.
During this webinar, we’ll discuss:
- FDA CDER Quality Metrics guidance
- Resulting benefits to the pharmaceutical industry and its patients
- Potential challenges to implementation across various segments of the pharmaceutical industry
- A breakdown of each of the metrics
- Implementation approaches
- Pilgrim SmartSolve® touch points for CDER metrics
Save your seat now to make the prospect of CDER Metrics less frightening for you and your team. Can’t make it? Register anyway, and we’ll send you the on-demand recording to view when your schedule allows it.