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
citation 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 for 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 specs of their labels.
Steve’s words were telling, 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 and 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 2
nd most common infraction cited was failure to
establish specifications.

Couch compares the pharmaceutical regulations to the 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 8 years.

Companies can avoid these 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.

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