The Office of Pharmaceutical Quality at the Food and Drug Administration (FDA) recently published its fifth annual report on the state of pharmaceutical quality. The report provides an in-depth analysis of the current state of the drug manufacturing industry, highlighting strengths, weaknesses, and opportunities for improvement. Here are the key takeaways:
Remote Regulatory Assessments Needed Due to COVID-19
The FDA published guidance on “Conducting Remote Regulatory Assessments (RRAs)” to provide an alternative tool during the pandemic. This allowed the FDA to triple the number of surveillance inspections in FY2022 compared to FY2021.
FY2022 Saw the Highest Number of Recalls in 5 Years
37% of these recalls were associated with four events:
- Temperature abuse
- Product held outside required storage temperature conditions
- Current Good Manufacturing Practice (CGMP) deviations
- Manufacturing with a contaminated excipient
Median Site Inspection Score Similar to Previous Years
The median site inspection score for FY2022 in the U.S. was 7.17. This number is similar to previous years. The scores can range from 0-10, with 10 indicating higher CGMP compliance. Sites with more than one recall in FY2022 had a noticeably lower median SIS of 4.96, suggesting low site inspection scores are connected to recalls.
Targeted FDA Sampling & Testing Approach Is Working
The FDA tested 1,552 samples in FY2022 and found over 57% to be non-compliant. This does not represent the quality of products overall, as the FDA embraced a more targeted strategy in 2018. Samples are chosen to be tested based on a range of risk factors including information from FDA investigators, manufacturers, patients, consumers, and trusted regulatory partners.
Initiatives Show Commitment to Quality
There are several ongoing initiatives to improve quality:
- New Inspection Protocol Project (NIPP): The NIPP is improving the FDA’s inspection program by enhancing how data is recorded, evaluated, and reported. Automated data pre-processing and advanced predictive tools are creating a clear path for assessing quality, recognizing policy needs, informing regulatory decisions, and enabling predictive capabilities.
- Quality Management Maturity (QMM): The Center for Drug Evaluation and Research is continuing its development of a QMM program. The proposed plan includes management commitment to quality, business continuity, technical excellence, advanced pharmaceutical quality system, and employee engagement. CDER published a white paper on its pilots titled “Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals.”
- The CARES Act: The CARES Act improves the FDA’s visibility into the drug supply chains and allows for better prevention of drug shortages.
You can read the full report on the State of Pharmaceutical Quality here.
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