Our Auditing Services


Another Set of Eyes

As an independent GMP Auditor, what is my main job? To determine the health of your GMP Program. I will deliver my unvarnished opinion, back it up with detailed observations that will give you a roadmap for improvement.

I'm sure your staff is great, but all of their time and energy is devoted to running your business. A professional auditor brings an outside perspective, and has the time to focus strictly on GMPs.

Using staff interviews, document review, and facility inspection I will scan your operation for possible violations and weak areas.

  • Do you have all the SOPs needed for your type of operation? Are your SOPs written properly and maintained?
  • Are your employees actually doing what your SOPs say they must do?
  • Is your documentation and recordkeeping in good order?
  • Are your suppliers complying with FDA cGMPs? Are they actually performing according to your Business Contract AND your QA Agreement? (btw - do you have a QA Agreement?)

Using established industry GMP audit templates, I'll generate an invaluable and confidential report. These findings will enable your staff to look at potential problem areas before the FDA inspector comes knocking.

Find out which of our Auditing services might benefit your company most right now. Simply click on the links in the sidebar to learn more.

Or contact us to talk about GMP Auditing.