Certified? We have had several customers ask recently about the new Dietary Supplement GMP’s, and one of the most misleading rumors has been that companies need to be certified or have some kind of “FDA certification”. This is simply not true. The FDA does not, and will not come to your facility and certify that you are compliant. They will inspect your facility and evaluate your level of compliance to the official GMP regulations.
To add to the confusion, there are several companies that do provide “certification”, like NSF. The FDA has not provided approval for NSF to go to companies and certify them…they simply do not do that. Just because you are certified by a company like NSF does not mean you will be compliant with current FDA GMP’s. It only means you are certifying that you have met the NSF requirements, which has turned into a marketing tool. Just look at the ads and company’s propaganda and see how many say they are NSF GMP Certified. I’m not saying that NSF, or other companies that provide “certification” are not providing a good service, they are! I’m simply trying to make it clear that being certified by anyone does not mean a company will meet the FDA’s GMP regulatory requirements and suddenly become compliant.
Our goal has been, and continues to be, helping manufacturers understand what it means to become FDA compliant and remove the confusion. Our “GAP” analysis is the best place to start and this is something we can help you with. A GAP analysis simply establishes where a company is now, and where they need to be. We help to develop on-going strategies to meet or exceed cGMP’s. The little “c” in “cGMP’s” stands for “current”, meaning that companies cannot just complete a few tasks and thus, they have arrived and can be certified; no such thing. A company must develop an on-going philosophy of continuous quality improvement.
So what do you need to do? In 2 ½ hours you can get a much better grip on it by listening to our session on Dietary Supplement GMPs 101 – New Ruling at https://techceuticals.webex.com. Then call us and find out what a GAP Analysis audit can do for your company.