The Food and Drug Administration Safety and Innovation Act (FDASIA) provides the FDA the ability to conduct electronic inspections and target on-site inspections based on metrics. The agency intends to request quality metrics data reports from the industry for a one-year period in electronic format through the FDA Electronic Submissions Gateway (ESG). Analysis of these data – such as the number of lots attempted of a product or the number of specification-related rejected lots of a product, etc. – would be used to grade companies on a curve and to provide them a “grade”, representing their fit on a curve. The FDA would direct resources to those companies who are on the lower end of the curve.
Risk-based inspection schedule
The FDA intends to open the ESG in January 2018 to receive voluntary submissions of data generated in 2017. It expects to begin data analysis when the portal is closed and publish initial findings on its website. The results of the voluntary phase will be evaluated and the FDA will then initiate a notice and comment the rulemaking under its existing statutory authority to develop a mandatory quality metrics reporting program.
According to the latest published guidance, quality metrics data will be used to:
- Establish a signal detection program as one factor in identifying establishments and products that may pose significant risk to consumers
- Identify situations in which there may be a risk of drug supply disruption
- Improve the effectiveness of establishment inspections
- Improve FDA’s evaluation of drug manufacturing and control operations
The guidance document specifically states that the FDA is continuing to encourage the adoption of emerging technologies and will request comments on implementing new technology while maintaining a robust quality metrics program.
The FDA’s e-inspections program based on quality metrics is a key step in its objective to encourage the industry to implement state-of-the-art, innovative quality management systems that drive the industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.
MES is the key to support quality metrics
To show regulators their commitment to quality, most companies will be forced to discontinue the use of paper batch records in favor of electronic batch record systems and MES. The integration of MES with complimentary systems like QMS, PLM and LIMS will play a key role in achieving a single source of truth to support quality metrics reporting.
On which end of the grading curve are you prepared to find yourself?
Daniel R. Matlis, President at Axendia