“I guess the question I’m asked the most often is: “When you were sitting in that capsule listening to the count-down, how did you feel?” Well, the answer to that one is easy. I felt exactly how you would feel if you were getting ready to launch and knew you were sitting on top of two million parts — all built by the lowest bidder on a government contract.” John Glenn, military pilot, astronaut, U.S. Senator

Something of this applies in the life science industry as well. It may be possible to get a product or service cheaper by finding a company willing to provide it for less, but are there risks that go with the lower price?

Well, there are risks with the high bidder as well—there are risks associated with any life science supplier. For example, a key supplier for a drug development program ran into trouble with the FDA. And since the supplier was in a foreign country, it was not possible to import anything from them into the United States. You can imagine the monkey wrench this threw into the drug development effort!

 

As with any risks, there are ways to mitigate them:

  1. Due diligence: Check on the firm’s history, review the advisors’ biographies, and request recommendations from other clients. Then, ask questions. Have you been audited by any regulatory bodies in the past three years? What were the results? If the FDA has been to the firm, you can ask them to share the Form 483 where the FDA investigator records his or her observations and concerns. If the firm tells you that it cannot share the 483 with you because it contains information proprietary to another client, you can ask for a redacted version. If a potential supplier remains unwilling to share this with you, it may be possible to obtain the equivalent information from the FDA’s website, particularly if FDA issued a Warning Letter. Of course, if FDA issued a Warning Letter, you should ask the firm to disclose how they addressed the issues raised by the Agency. Again, if the firm is unwilling, then you should take that as a warning yourself.
  2. Auditing: Another way to assess your current or potential suppliers is via an audit. A quality audit is a visit to the supplier’s facility by experienced and trained individuals who know how to ask the right questions, what to look for, and how to analyze the paperwork (electronic or otherwise) that show how good the supplier is at providing quality work. A quality audit can identify potential problems that you can work with the supplier to resolve before the FDA raises the same issue. And, of course, if the supplier is not cooperative in addressing concerns found during the audit, that tells you something, too.

That’s not the only benefit of an effective quality audit. Auditing key life science suppliers during the development process can increase the value of the medical product you are developing. Providing investors and potential partners solid assurance that there are not likely to be any “surprises” when regulatory agencies check out your supplier is of real value.

Do you need to do the audit yourself? Of course, you can, but do you want to take time away from the product development process? Do you have the background and knowledge necessary to do it? Pearl Pathways’ trained and experienced staff can perform the audit for you, making your life easier and increasing the confidence that you and your investors and potential partners have in the likelihood that your drug will be successful. Learn more about our auditing services.