Since the Continued Process Verification (CPV) guidance in 2011, the U.S. Food and Drug Administration (FDA) has been talking quality and verifying process state of control.
Now the FDA is getting around to defining what that looks like and what data they want to verify quality. However, the FDA’s push is leaving more questions than answers about what specific date they need, how they will use it, and what implications that holds for manufacturers.
The first public meeting to discuss the FDA’s Quality Metrics Guidance was held recently on August 24th, at the FDA headquarters in Silver Spring, Maryland. Those presentations can be found on the FDA Quality Metrics Public Meeting page.
It’s the FDA’s intent to use these newly created metrics for benchmarking purposes for similar industry markets or manufacturing processes. However, no definition or reasoning was given to the attendees on the implications or meeting, exceeding, or failing the industry benchmarks.
The FDA says the program is intended to:
Develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.
The organizations in attendance were concerned it will be implemented to guide inspections. The FDA believes:
…a careful analysis of quality metrics can help the FDA better identify which facilities are at the highest risk for quality problems. This will help [them] use [their] inspection resources most efficiently and effectively.
However, like car insurers wanting to track drivers’ habits, the negative implications of participating may outweigh the risk of additional inspections. This is a double-edged sword. The guidance may prove a net benefit in overall product quality, but the burden of collecting and submitting the necessary data may slow production of necessary drugs.
While this is still in its defining stages, manufacturers have opportunities today to begin preparing and putting themselves ahead of these changes. The guidance states “the use of new, in-line analytical technology used for real time release testing with increased sensitivity” plays well into Emerson’s Batch Analytics capabilities and technologies, an enabler for pharmaceutical and biotech manufacturers in achieving CPV.
From Jim: you can connect and interact with other pharmaceutical, biotech, operations management and batch experts in the Life Sciences, Operations Management and DeltaV groups in the Emerson Exchange 365 community.