Posted on March 08, 2022 | By
The U.S. Food and Drug Administration (FDA) on Wednesday outlined a streamlined plan to collect quality measurement data from drugmakers in a bid to renew its previously stalled efforts to obtain quality data. manufacturing to alleviate potential drug shortages and promote better quality. management in the pharmaceutical industry.
The agency stressed in an announcement that this plan will differ from the original draft guidance on quality indicators unveiled in 2015, as well as the revised draft guidance released in 2016. The newly designed plan is based on feedback that received thanks to its voluntary quality indicators. site visit and quality metrics feedback programs launched in 2018. (RELATED: FDA Releases Long-Awaited Guidance on Quality Metrics, Regulatory guidance July 28, 2015; Quality Indicators for Pharmaceuticals: FDA Unveils Two New Voluntary Programs, Regulatory guidance June 28, 2018)
“The FDA has applied lessons learned from the pilot programs and other stakeholder feedback to refine the QM reporting program that was outlined in the revised 2016 draft guidance,” the agency said.
Industry opposed the 2016 revised quality metrics proposal due to the burden and high costs of collecting this information, leading the FDA to adopt the two voluntary programs two years later. . (RELATED: Industry wants FDA to rein in quality metrics programRegulatory update, March 30, 2017).
Through feedback, “Stakeholders indicated that different industry sectors may prefer different measures of quality. To provide flexibility to manufacturers, the FDA would focus less on standardizing quality and definitions,” the agency notice states. “Instead, the FDA would identify the practice areas that are critical to ensuring sustainable product quality and availability and allow manufacturers to select one or more measures from each practice area that are meaningful and would allow the establishment to identify opportunities for continuous improvement.
The FDA explains that meeting current Good Manufacturing Practices (CGMP) requirements is the “minimum standard” for ensuring safety and effectiveness, “CGMP does not necessarily indicate whether a manufacturer is investing in improvements and strives for sustainable compliance, i.e. the state of having constant control over performance and manufacturing quality.
The FDA has identified four areas, and the individual metrics in those areas, if any, for reporting:
- Performance of the manufacturing process: this may include the proportion of batches that have been accepted in a given period as well as the proportion of batches manufactured without non-conformance;
- Pharmaceutical Quality System (PQS) Effectiveness: This measure may include Corrective Action and Preventive Action Effectiveness (CAPA) which may cover the number of CAPAs initiated or closed on time;
- Laboratory performance: This may include the proportion of laboratory tests that are completed on time;
- Supply chain robustness: This may include the extent to which shipments are delivered on time and contain the correct quantity.
FDA seeks specific comments on the following: whether reports should be aggregated at the facility level; whether facility-level reporting would facilitate CMO submission of data on quality metrics; useful definition of a “product family” for reporting purposes; and the components of a “robust” quality culture if the FDA decides to include it as a metric.
The FDA also asks if there should be unique considerations for different product categories, such as generics, over-the-counter (OCT), or biologics and what the optimal frequency of notification would be.
In addition, the FDA wants to know if any of the proposed measures “fall short of the goals” of the program and what other measures should be considered.
The deadline for submitting comments is June 9.
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