FDA Inspection? Rely on Your Vendors

If you’ve spent a reasonable amount of time in an FDA-regulated industry, you’ve most likely been part of an FDA inspection. Should you be more fortunate, you have participated directly with the Inspector(s) or been part of the “War Room”. Inspections happen and they can be nerve-wracking. There are many questions to answer, tours of the facility, and documents to prepare and submit to the FDA. For those that have participated directly with the FDA in the Inspection Room, there can be a free-flowing dialogue of questions and answers. Of course, many of the answers provided by the company need to be backed up by documentation.

During a recent FDA inspection, one of our clients was asked a particularly difficult question by the FDA: Can you show me the cleaning validation of your pH probe used in the Formulation area? This came as quite a shock to our Inspection support team. How could the firm demonstrate cleaning of the pH probe between formulations? To the knowledge of the client and the ProPharma team, no cleaning validation had been performed between uses of the pH probe during regular formulation activities. Looking around the room, there was over 200 years of combined FDA regulated industry experience. Not one person could recall a question like this during an inspection. During our discussions, a great idea was presented: Let’s call the manufacturer of the pH meter and discuss with their technical experts.

Once on the phone with the pH meter experts, they confirmed our initial thoughts and ratified our internal SOP.

• The pH probe is standardized on a daily basis
• The probe is rinsed between uses with a sterile solution
• The sterile solution is changed daily

The technical experts at the vendor also confirmed that this practice is not only their recommended usage, but collective industry usage. Knowing this, the firm was able to satisfactorily answer the FDA’s question without performing a retrospective cleaning validation between the formulation of each product. Another great lesson was learned from this experience: Stay in close contact with the Technical Services department at your critical vendors. The Technical Services representatives are usually a short call away, but prudent advice would be to have supportive documentation on hand that would be helpful during an FDA inspection. So, when is the last time you spoke to a Technical Services representative at your critical vendors? Maybe it’s time for a call…

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