cGMP Certification and Appreciation For My Team

As many of you know, last year we got our lab ISO 17025 accredited. It was a lot of hard work from my team to do, and we ended up getting a perfect score. Not a single thing was brought up by the auditor. They were impressed at our systems and organization. I was actually surprised. I suppose I shouldn't have been, since we put so much work into things. However, you are always nervous going into things like audits. It's nice getting some validation in all our hard work by independent 3rd party inspectors. I am very proud of my team for everything they put into getting our lab up to the level it is today. We are also part of the NIST (The National Institute of Standards and Technology) proficiency testing program now as well. After we got ISO certified, we signed up as part of the NIST lab proficiency program. This has us participate in lab testing of known samples, and our accuracy/precision in results is plotted against all the other labs participating in the program. The first samples we participated in were actually cannabis products. We are also using our work on cannabis testing to certify our lab with the Arizona Department of Agriculture, which we will then use to become DEA licensed as an analytical lab for the testing of scheduled/controlled substances. It's the next step in expanding the certification of our lab! This brings us to today's topic: cGMP.

We have always followed cGMP guidelines. However, we never felt the reason to go and get cGMP certified by an independent body. It didn't seem like is was worth the time, effort, and cost associated. We knew we were following and exceeding cGMP guidelines, so why pay another company to come in and tell us what we already knew? Then Amazon changed their rules. A few months ago, Amazon decided to change their rules about products. Any product that could not show documentation that it was made in a cGMP certified facility would be pulled from Amazon. It didn't matter if you were compliant with the regulations. You had to start showing a document certifying it. It's not a bad idea, in theory. It's just something that normally takes longer than a few months to accomplish. This is especially true when you force everyone to do it at the same time. We focused on ISO accreditation for the lab earlier in the year. It would have been nice to have more time to not scramble, but that is not how Amazon works. Regardless, it was a new compliance step that needed to happen, so my team rallied together to get it done in an insanely fast amount of time.

I am happy to say that now we are both ISO accredited and cGMP certified! We once again got a perfect score. No out of compliance findings to report. Moreover, the auditor that came in to inspect us said that we are in the top ten cleanest and most organized facilities he has ever been to, out of the thousands of facilities he has inspected over the years! Again, I guess I shouldn't be surprised. I know the level of care and effort we put into being the best we can be. However, it is really nice to have objective confirmation of that our efforts really are above and beyond the standard! This is an auditor that has seen an insane amount of FDA registered facilities around the world. To have him say that we are in the top ten he has ever seen feels really good! It makes the effort we put into accomplishing that all worth while. We also had a second cGMP audit from another company a couple weeks after the first. We originally scheduled one, and signed the paperwork, but they had some delays in being able to get out to us, so we scheduled another certification company to come out a bit sooner. This means we had two cGMP audits back-to-back. The second auditor also had no findings. A perfect score from them, too. Extra confirmation is always nice!

I want to congratulate everyone on the ND team for this accomplishment! I am really proud of them for the effort they put in to get these certifications. The fact that we have perfect scores for both our lab and manufacturing side, and were told we were in the top ten cleanest and most organized facilities they had ever seen, is just icing on the cake! It makes me proud of my team, and proud of all the work we have put in over the years to hold ourselves to a higher standard.