Every day I work with companies that are looking to find innovative solutions that mitigate compliance risk.
I was invited to PDA Midwest’s Risk Mitigation & Sterility Assurance Event to share what FDAzilla has found the best practices in supply chain risk mitigation are:
Befriend the Invisible FDA Inspector (sort of)
To start, I asked the crowd if anyone had a CMO get inspected and receive a 483, but the CMO didn’t tell them. Many hands shot up, and it’s no surprise.
Several pharma companies (large & small) have told us that they were not only surprised that their CMOs received warning letters, but they oftentimes didn’t even know that their CMOs were inspected!
Treat the FDA inspector who recently inspected one of your CMOs as a virtual member of your team: if they just wallopped your CMO with a 483, use that document to guide your next audit so you are prepared with the right questions.
Skip the Business Flight
If your CMO passed their inspection with flying colors, you can do a paper audit guided by the EIR rather than spending the resources on an in-person audit.
Approaches will vary on a case by case basis, but it is critical to identify risk and create metrics that determine your next steps. Aim for a data-driven & risk-based approach to auditing.
Work with the Right People (yes, that includes FDAzilla)
With almost 20 years of inspection data, 11,000+ 483s, and our rapid database additions every week, there’s no hiding from us! With our services, you can make sure that you choose a reliable CMO by:
- Getting Benchmark Reports. Not all CMOs are created equal. If you can access and understand industry trends through our benchmark reports, you can at least find the cream of the crop CMOs.
- Monitoring Everybody. You can’t make an informed decision without the right information. FDAzilla will monitor your entire supply chain (and even your competition) to make sure nothing is missed. Eliminate surprises.
- Zooming Out. Don’t just look at 1 site — look at all of the company’s sites. If there are systemic issues plaguing their other sites, then you know it’s probably only a matter of time for those issues to spread to the site you are working with.
The PDA Midwest Board Members were fantastic to work with and created a fun and informative all-day event. I look forward to the next one!
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at firstname.lastname@example.org.
*Header image provided by PDA Midwest.
About the Author
Ben Anderson is FDAzilla’s Senior Account Executive.