Third Party Labs: Why Certification Matters

Third-Party Labs: Why Certification Matters

White Paper

by Brent Ristow, PhD, JD


A recent letter from the FDA, titled “Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions,” warns pharmaceutical and medical device marketers to exercise caution when engaging third-party labs.

Your NDA, ANDA, PMN, and/or PMA will likely require you to engage with a network of labs capable of supporting various services intended to support those filings. These networks of labs support API, synthesis, formulation, manufacture, testing, and release of pharmaceuticals and biologics. And provide development, manufacture, and testing of medical devices. The testing service these labs offer is a core component of your application CTD.

These testing services should emphasize compendial and industry guidance compliance for the vast array of testing likely required for your project. If your lab is not publicly demonstrating ISO certification, then it is not publicly demonstrating that it is following industry best practices.

The data generated during your study must be supported by complex IT infrastructure and documents generated in a highly controlled environment to ensure its integrity. If your lab is not ISO 9000-9004 certified, it is not publicly demonstrating that it has systems and processes currently in place to ensure the integrity of your data.

Your study will involve method establishment activities. These activities will require analysts to establish methods specific to your API, excipients, device components, etc., to ensure the integrity of your product. If your lab is not ISO 17025 certified, it is not publicly demonstrating its technical skill and ability to meet the rigorous requirements of method establishment activities. 

Class II and III devices will require extractable and potentially leachable testing, the extent of which will depend on your device, its component composition, formulation, size, surface area, dose, duration of exposure, and route of administration. If your lab is not ISO 10993 certified, it is not publicly demonstrating that it fully understands the scope of what the FDA expects from you in your requirement to demonstrate compatibility with biological organisms, mainly humans.

Obtaining FDA approval down a road paved by third-party testing labs is a journey fraught with bootleggers and pirates. Mitigate your risk by engaging with a lab that publicly demonstrates compliance with industry standards and best practices. The FDA is watching.



-Brent Ristow, PhD, JD

Founder, Brighton Ashford, LLC

Boutique Pharma & Med Device Consulting