What It Means to be a GMP Certified Facility
The statement, "this is a dietary supplement (DS) cGMP-certified storage facility," should catch the attention of every supplement brand owner/manufacturer looking for a storage solution. Along with being two fairly popular trains of thought, these happen to be two of our favorite reasons why that first statement should capture your attention : 1) Working with a cGMP-certified storage facility is a great way to help your products and materials maintain their quality and efficacy, and 2) To put things rather bluntly, the FDA does not like to mess around when it comes to abiding by the established cGMPs.
Keeping those in mind, it shouldn't come as much a surprise that the majority of us within the industry do choose to work with cGMP-compliant facilities from the very start of our supplement endeavors. Now, what may indeed come as a surprise is the fact that, for many of us within the industry, recognizing a cGMP-certified facility is near impossible without the help of a third-party provided certificate exclaiming, in clear print: "This facility has been cGMP-certified."
Now, in all fairness, a legitimate and up-to-date cGMP-certificate should be more than enough. But, for those looking to be even more informed, these are the basic qualifications that astorace facility/warehouse must meet in order to be considered DS cGMP-compliant (as per everyone's favorite piece of dietary supplement literature, the DS cGMP master manual, CFR Title 21, Section 111).
Things a storage facility or warehouse must do in order to earn a cGMP-certification:
- Keep dietary supplements, their various components, packaging and labels under the appropriate temperature, humidity, and light conditions as to avoid obstruction of identity, loss of purity, loss of potency, and changes to composition.
- Keep and hold all in-process materials under appropriate temperature, humidity, and light as to avoid obstruction of identity, loss of purity, and changes to composition.
- Keep and hold all in-process materials under conditions that work to prevent contamination, deterioration, or general “mix-ups.”
What’s the primary takeaway here? The terms that dictate what makes for a “cGMP-certified” storage facility are actually pretty simple – provide humidity and temperature controls and prevent product cross-contamination and degradation of any kind.
The bottom line? Working with a cGMP-certified storage facility is one of the easiest ways to help maintain the integrity of your products and your business.