By Phil Crooker, VP – Technical, Regulatory & Access, Parexel
Beginning in 2014, over six years ago, the FDA has unveiled a cornucopia of efforts to incentivize regulated industry to participate in a quality metrics program. This has included publications in the peer reviewed literature, public meetings, webinars, blogs, several programs described in Federal Register notices, a draft and revised draft guidance, reports from FDA and cooperative research with academia. Industry kicked in a report as well. You can find all these materials in one location on the FDA website here - https://www.fda.gov/drugs/pharmaceutical-quality-resources/quality-metrics-drug-manufacturing.
In the latest turn of the long road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM). One program is dedicated to domestic manufacturers of drug products and the other is dedicated to foreign manufacturers of active pharmaceutical ingredients (API). You can find the announcements from the Federal Register here https://www.federalregister.gov/documents/2020/10/16/2020-22976/quality-management-maturity-for-finished-dosage-forms-pilot-program-for-domestic-drug-product and here https://www.federalregister.gov/documents/2020/10/16/2020-22977/quality-management-maturity-for-active-pharmaceutical-ingredients-pilot-program-for-foreign.
Both announcements are relatively short (2 pages for the domestic drug product program and 3 pages for the foreign API program) and nearly identical. Each announcement includes the dates for operation, a background section and a section with instructions for how interested manufacturers can participate. Here’s a quick look at the core elements that are discussed in both announcements.
- FDA will accept applications from manufacturers who are interested in participating in the pilot through November 30, 2020. The pilot programs will end on December 31, 2021.
The notices reference several of the agency’s past efforts to incentive industry to modernize its manufacturing systems, including the “Pharmaceutical CGMPs for the 21st Century – A Risk Based Approach” initiative that began in 2002, the revised draft guidance Submission of Quality Metrics Data published in 2016, the quality metrics site visit program and the quality metrics feedback program and the report on drug shortages recently published in 2019.
- Elements of a mature quality system include the ability to consistently and reliably deliver quality product over time, operational stability and strong quality culture.
- FDA offers the possibility of a more flexible regulatory approach with firms that have a mature quality management system without extensive regulatory oversight.
- A third-party contractor identified by the FDA will assess a facility’s quality management system (QMS) accompanied by FDA staff.
- The results of the assessments will be used to develop a rating system to measure and rate QMM.
- The notices include a list of 11 topics that will be included but the programs will not necessarily be limited to only those topics.
- FDA will select up to nine participants for the programs.
- The pilot program for domestic manufacturers of drug products is open to firms producing prescription or over-the -counter (OTC) products.
- One of the selection criteria is that all FDA inspections conducted in the last five years prior to Sep. 15, 2020 resulted in either a “no action indicated” (NAI) or “voluntary action indicated” (VAI) classification.
- The assessment by the third-party contractor may be conducted on-site or remotely.
- FDA will provide the participants with templates for the data collection.
- Information that should be included with the application includes:
- Complete facility information (same as that expected to be provided in an ANDA, NDA or supplemental application).
- Brief description of manufacturing operations conducted at the facility.
- Preferred dates for the assessments.
- Written confirmation that the facility meets all selection criteria and that the facility can host up to 10 FDA staff and contractors.
- Brief description of any prior QMM assessment.
The quality metrics and related programs for risk based CGMP and use of regulatory discretion offer opportunity for industry in modernizing its manufacturing operations. The program for quality metrics is significantly less mature and more controversial than the “Pharmaceutical CGMPs for the 21st Century – A Risk Based Approach” initiative and the implementation of a quality metrics program has been turbulent so far. These pilot programs show that FDA is still committed to developing and implementing some type of quality metrics and QMS rating system for a variety of purposes. Before setting off on the journey with these pilot programs, manufacturers are well recommended thoroughly evaluating several interesting issues with short and long-term implications while balancing those against the merits and advantages of participating.
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