FDA Inspections and the New Paradigm
What are your biggest concerns about an FDA Inspection?
- Non-compliance with cGMPs.
- Won’t know the answers to the investigator’s questions.
- Won’t have complete documentation.
- Concern about which investigator will conduct the inspection.
- Will not be prepared when the FDA comes to inspect.
- Will interfere with my Thursday night golf league.
What was the reason for your last FDA inspection?
- Pre-Approval Inspection (PAI)
- Post-Approval Inspection
- Routine Surveillance Inspection
- For-cause or Directed (Recent recall or submitted an increased number FARs to the FDA, etc.)
The New Inspection Protocol Project (NIPP) is a new paradigm for inspections and reports that are aimed at advancing pharmaceutical quality, standardizing the approach to inspections, and creating a methodology to better predict product and drug shortages. It is a risk-based and rule-based process using expert questions and gathering data to inform “quality intelligence” of sites and products, both positive and negative.
Although cGMP compliance is still very important, the Office of Pharmaceutical Quality (OPQ) has made it clear that compliance alone might not be good enough. They want pharmaceutical companies to “up” their game. The question they are asking is: “What is your quality culture, and how do you measure it?” As we all know, if you measure something directly, then we all tend to focus and work to improve it. Do you know if your quality culture is sufficient? How do you measure it directly, and intentionally improve it? Having the ability to quantitatively measure the quality culture of the organization will allow for comparative scoring among drug makers and better anticipation of drug shortages. The metrics used are leading quality indicators and are direct evidence of the organization’s quality culture. If these indicators are not present, then it is a sign that the company may not have a quality culture, or be able to quantitatively measure it, or know how to improve it on a continuous basis.
If you are interested in learning more about how you can be prepared for the FDA when they visit you the next time, please contact me at firstname.lastname@example.org.