Vendor Qualification – What Can Go Wrong

August 12th, 2011 by

As Calcott Consulting spreads its wings and extends its reach into the Pharmaceutical and Biotech industry, it is time to start a blog. This is the first (and hopefully not the last post).The topic for today is VENDOR QUALIFICATION.

I routinely review FDA warning letters every month or so to see how the industry is faring and to get new information for all my classes and training sessions and the one that caught my eye was this topic. I think we are all aware of the Baxter – Heparin incident and how a lack of oversight brought disaster to the company and also its Chinese vendor of heparin. It did also cause quite stir in the industry and with the public at large.

Is this an isolated incident or is part of deeper issue in the industry? I think the latter.

I see in my audits lcak of clarity in these programs to qualify and manage vendors of services and materials whether it be a testing lab, a provider of services eg. maintenance or raw materials. Too often when I ask the question “show me your vendor managemnt or qualification program”, I am presented with an audit of the company. Similarly, when I scan and read the group discussions in LinkedIn, I am amazed by some of the questions that indicate a lack of understanding of the first principles of what needs to be done. And this is by people who are in the field in senior positions.

So what are they doing wrong. I have included some links below to go directly to the warning letters but companies who fail clearly demonstrate at least a few of the following:

  1. Delegation of all responsibility and accountability to the service provider. It does not matter who does the work, you are still responsible for the outcome.
  2. No objective demonstration that the vendor can provide what they say they can do.
  3. No tracking of performance to assure the vendor continues to provide the service at an acceptable level.
  4. Accepting sub standard materials and services

This is to name but 4. Read through the attached links to see the details.

Warning Letters to Allure Labs, Scientific Protein Labs, and Toxin Technology Labs

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