Most Common GMP Citation for Supplement Producers: Not Establishing Specs

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Most Common GMP Citation for Supplement Producers: Not Establishing Specs

A few weeks ago, the Rocky Mountain Dietary Supplement Forum saw who’s who of the dietary supplement industry converge in Boulder, Colorado. According to this article by Josh Long of Natural Products Insider, numerous FDA officials gave presentations regarding their experiences and noted that failing to establish specs is the most common GMP citations in the dietary supplements industry.

One presenter provided data from fiscal year 2015 and noted that out of 303 total inspections conducted under Part 111, 16 percent of the GMP citations were for not being in compliance with 21 C.F.R. Part 111.70(e) or failing to establish specs. 14 percent of inspections were cited for failing to verify the ingredients’ identity through some sort of test or examination process, which would be a violation of 21 C.F.R. Part 111.75(a)(1)(i).

While companies are being penalized for failing to meet those standards, overall, the citations are declining. Companies are encountering fewer violations of other regulations, such as failing to have master manufacturing records (MMRs).

In fiscal year 2013, about 19 percent of FDA inspections were related to violating Part 111.75(a)(1)(i). In FY15, those violations dropped to 13.5 percent. FDA regulations can be difficult to understand, but industry officials are encouraging companies to seek cGMP compliance, and there are many resources out there to break down these rules.

Nancy Schmidt, a compliance officer based out of Denver, said that the most common cGMP infraction was failing to establish specifications for the identity, purity, strength, and composition of batches of finished dietary supplements.

Kathleen Torney, an FDA investigator from Denver, mentioned that she mostly encounters companies that have failed to outline specifications or have “unrealistic” specifications. Some claim they can’t test the materials or that they can visually tell based on blending.

So how can companies put out products that are good quality if they are not properly tested? Marian Boardley, an independent consultant and friend of InstantGMP, wonders if there are no established identification tests.

Many own-label distributors seem to misunderstand their obligations under Part 111, according to Steve Mister (President and CEO of the Council for Responsible Nutrition). They rely on contract manufacturers and don’t realize that they are responsible for providing the specs of their labels. Steve’s words were saying that distributors have a responsibility under Part 111 to know exactly what is in their product.

Tara Lin Couch, Ph.D. is a senior advisor with EAS Consulting Group LLC works specifically with dietary supplements; she mentions that establishing these specifications can be challenging for a number of reasons. She notes that the companies have to be familiar with all aspects of the product, from the supply chain, the raw materials, and the master formulation. The information has to be there for specifications to be created,  and because so many companies outsource their manufacturing to contract labs, they are taken out of the loop or have no idea where to start.

Companies also have to enact some sort of testing or examination for verification. Kathleen Torney said that these companies fail to conduct tests or fail to use a valid scientific testing method.

This is a well-known issue within the dietary supplement industry; one in five facilities received Form 483 in FY14 because they failed to verify the identity of an ingredient prior to using it through a test or examination. The 2nd most common infraction cited was a failure to establish specifications.

Couch compares pharmaceutical regulations to dietary supplements and notes that it took 20+ for pharma to comply with manufacturing regulations, dietary supplements have only been familiarized with GMP regulations for about eight years.

Companies can avoid these GMP citations by implementing a manufacturing management record system to specify their materials and testing methods. InstantGMP produces a cloud-based software solution that reinforces good manufacturing practices. Check out our demo page for more information.