In 2015, the FDA released their Request for Quality Metrics draft guidance, describing the measurements they’ll use to evaluate the quality of drug and biologic manufacturing.
But despite the many resources FDA has made available to help educate manufacturers on the use of collected data, companies are still struggling to understand what exactly the Agency wants to see in the data.
Many companies have trained themselves to focus on best practices determined by industry groups, but at the end of the day, it’s the FDA’s quality metrics criteria that matter most.
With that in mind, here are four things the FDA recommends for companies preparing their products for metrics reporting requirements:
Context is crucial to making metrics meaningful. Simply arriving at a number means very little without providing the answers to the following questions:
• What is the number defined as?
• What are the constituent inputs to that number defined as?
• How (in detail) did you actually establish that number?
Meaningless numbers only create more questions than they answer. An effective readiness initiative considers all of the possible questions the FDA might have about the data and answers them before they’re even asked.
Take the time to anticipate every possible question raised by the metrics you provide and use that list to ensure you’ve given all the context necessary to make those numbers mean something.
Every figure you report to the FDA should be accompanied by a clear explanation of how you derived it.
All numbers tell a story, which is exactly what the FDA expects to glean from your report. Keep in mind that when providing derivations, accuracy is extremely important as these items will be checked during subsequent inspections.
While it’s the FDA’s mission to ensure products are safe and high quality, the way they prefer to do that is by helping companies develop processes and procedures to do it themselves.
For those submitting data to the FDA, it’s absolutely critical to answer the following questions:
• What is the review process from beginning to end?
• Who on your team is responsible?
• What are the timeframes for review?
• Where is the data coming from?
• How were your figures calculated?
• Who is submitting and approving?
Regulators have made it clear that data integrity will be a key focus in both their evaluation and enforcement efforts. With that in mind, it’s safe to assume that submitting weak and/or insufficient data will raise red flags and likely lead to greater scrutiny in the form of on-site inspections.
As companies increasingly rely on digital quality management systems to handle reporting, there simply is no system capable of collecting, reviewing and reporting metrics company-wide on a regular basis.
While newer, more powerful information tools are certainly on the way, companies still need to build a solid infrastructure incorporating staff members to review, report and approve operations as well as processes and technology that show consistency, efficiency and effectiveness.
The bottom line is simple: The FDA is expected to put far more importance on collected data, with quality metrics showing up on some companies’ timelines as early as this year. It pays to put a reliable, transparent metric system in place sooner than later.
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