Are You Ready to be Graded on a Curve?
The Food and Drug Administration Safety and Innovation Act (FDASIA) provided the agency with sweeping new statutory authorities, which have not garnered much attention by industry. A key FDASIA provision is the ability to conduct electronic inspections (e-Inspections) and target onsite inspection based on metrics.
By shifting to a metrics based approach the Agency seeks to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.
“…we want to encourage firms to prioritize quality and encourage their boardrooms and their pocketbooks because quality costs money,” stated Howard Sklamberg, J.D., FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.
To support this effort, FDA released for comment its Guidance on “Request for Quality Metrics.”
FDA intends to request quality metrics data reports from industry for a one-year period. The Metrics would be segregated on a quarterly basis in the report. Annual reports would be due to the agency within 60 days of the end date of the reporting period.
The Metrics reports would be submitted to the Agency in electronic format through the FDA Electronic Submissions Gateway (ESG).
FDA would then utilize analytics and business intelligence tools to:
- Develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers.
- Improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages.
- Encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.
The resulting analysis could be used to grade companies on a curve and provide a company a “grade”, representing their fit on a curve. According to Mr. Sklamberg, while FDA does not currently plan to issue company report cards, he explained that FDA would direct resources to those companies who are on the lower end of the curve.
The Carrot and the Stick
Based on its analysis of Quality Metrics across the industry, FDA plans to develop a risk-based inspection schedule. Establishments that show FDA their commitment to Quality and have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection occurrence) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection frequency).
In the event an establishment does not report required Quality Metrics, FDA may deem products manufactured or processed at that establishment as adulterated and subject to enforcement action.
Industry’s Support for Quality Metrics
It is important to note that Industry and FDA have collaborated in the development of these Quality Metrics. To support this effort, the International Society for Pharmaceutical Engineering (ISPE) conducted a Quality Metrics Pilot Program which defined a series of quantitative and cultural metrics aimed at supporting FDA’s e-Inspection program. See Axendia’s article ISPE, FDA AND THE METRICS FUTURE for additional details.
FDA’s e-Inspections program based on Quality Metrics is a key step in its objective to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving in product quality, rather than simply ensuring compliance to regulatory requirements.
While paper systems are still prevalent in our industry, the requirement to submit Quality Metrics annually in electronic format makes the use of aforementioned systems unsustainable.
Systems such as MES, QMS, PLM and LIMS will play a key role in supporting Quality Metrics reporting. The time to begin preparations is now.
Is your company, and are your systems, ready to be graded on a curve?
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The opinions and analysis expressed in this research reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.