Supplement manufacturing is a lucrative business worth billions of dollars, yet most supplement manufacturers use inappropriate testing methods. Most nutritional supplement manufacturers claim that their facilities are registered with the FDA. However, being registered with the FDA does not guarantee the purity of the ingredients used in private label supplement manufacturing and whether it complies with the set quality standards.
A dietary supplement manufacturing facility where the raw ingredients are not tested for their potency will likely bring devastating results for you as a label owner. How do you know that the products that are reaching customers are not lethal and detrimental to their health? A typical outcome for such irresponsible practice is facing a civil penalty. These penalties can go up to $2,500 per day and easily escalate to millions of dollars as the penalty is charged per each customer’s dose.
Here are a few checks and balances offered by PureNSM that set us apart from the rest of the competition and help you protect your brand image!
We offer in-house testing in a GMP certified facility.
Since our inception in 1993, we have invested in state of the art equipment, enabling us to manufacture supplements without manufacturing agents. We use specialized machinery for free-flowing and non-free-flowing powders in our facility. We have a strict quality control policy. We take no shortcuts and test every batch of raw materials sent to us by our suppliers. With years of supplement manufacturing, we know that even the largest raw materials suppliers often send spent herbs that are the leftovers from the extraction process. Still, as we have an in- house testing facility, such raw materials are always caught and sent back. As our suppliers know that we test every batch, we now receive only top-shelf raw materials from our suppliers. Every batch we receive is tested, and the results are always documented.
We go above and beyond cGMP.
PureNSM is Current Good Manufacturing Practices compliant by NSF, UL, and NPA. We have the capacity and expertise to manufacture 99% of the products at our facility. In some cases where outsourcing becomes inevitable, we inform our clients upfront and keep them informed.
Our business Nutritional Supplement Manufacturers, Inc., is certified to be in GMP compliance with FDA Reg 21 CFR 111, and we ensure a meticulous and systematic approach. PureNSM strictly adheres to Standard Operating Procedures (SOP). We also keep Master Production Records (MPR) for all products and assign Batch Production Records (BPR) to each batch of products manufactured in our facility. Each step we undertake is well documented; a typical BPR consists of more than 140 signatures and dates to ensure accuracy.
We Perform HPTLC testing for the identification of herbs.
PureNSM performs state of the art High-performance Thin Layer Chromatography (HPTLC) testing to ensure herbs’ identity. DNA testing might sound fancy, but it does not work on herbal supplements outlined by the US Pharmacopeial Convention. USP states that DNA testing is not appropriate for botanical extracts.
We perform finished goods testing.
Not performing finished goods testing is one of the most common FDA violations. FDA frequently sends warning letters to manufacturers who fail to perform finished goods testing of their products. It is necessary to perform finished good analysis not just because you would want to avoid Form 483 (FDA warning letter) but because untested finished products pose a serious threat to consumers’ lives. When it comes to supplements, the facility it was manufactured in is the last line of defense. Untested oil-soluble vitamins can cause those who consume it to experience kidney failure and death in the worst-case scenario; who would want to risk that?
PureNSM shares the latest information backed by the latest industry research and our years of experience as an excipient free state of the art supplement manufacturer. We want label owners to understand the risks a non-cGMP certified facility poses. A facility that does not apply identity and heavy metal analysis to test raw materials compromises consumers’ physical well-being, while also putting your reputation as a label owner at risk, which takes years to build.