The GMP Compliance Conundrum

The acting deputy director of the Division of Dietary Supplement Programs at the FDA, Cara Welch, Ph.D., left the author of this article with some confusing takeaways:

  • If you are a Dietary Supplements manufacturer
    who wants to learn good manufacturing practices, read the GMPs for dietary supplements
    and apply them, otherwise, you are at risk of receiving a Warning Letter

  • Larger firms are not receiving Warning Letters
    because they have resources to interpret the FDA, but smaller firms generally
    do not. The FDA has no comprehensive GMP compliance guidelines for dietary
    supplements manufacturing. Specifications, as an example, are the biggest issue
    when it comes to noncompliance, but there are no guidance documents on how to
    set them

  • Companies who can’t interpret the preamble are
    forced to rely on consultants if they can afford them. If not, they pose a
    greater risk to the public who consumes their products

  • Small firms need education, whereas the FDA is
    only focused on compliance

Devon Powell, the author of this article, pressed the FDA about whether or not they would change their
philosophy from enforcement-only mode and to shift to educating or guiding
companies towards compliance by demystifying setting up specifications,
documentations, and providing other valuable information.

The FDA’s focus is enforcement, not assistance. It brings up
the question, how a company can go about meeting requirements if no information
is available on how to meet requirements? The go-to response has been to simply
read the preamble. If you read the preamble, you’ll have everything you need
and know how to apply the rules. If you still can’t figure it out, hire someone
that can – that someone being a consultant or an employee with specialized
knowledge.

But what about the part where larger companies aren’t
receiving warning letters?

Generally speaking, large companies have more resources and
can afford to spend funds as necessary to hire consultants or employees with
GMP expertise. Smaller companies tend to lack those resources, and feel much
more of the burden to be compliant. They walk a thin line of ignorance and
denial. As the author notes, they operate under a mantra of doing (or not
doing) what they want until they are caught.

It would be ideal for the FDA to shift towards education,
but they are an agency that is stretched thin. GMPs are unique to a company and
the FDA can’t sit down with each company one-on-one, so the onus is with the manufacturers
themselves.

With the Dietary Supplement Health and Education Act of 1994
(DSHHEA), it’s virtually impossible for the FDA to police the industry given
the incredible amount of products on the market. There are an estimated 80,000
supplements being solid and the FDA is often playing catch up. It’s concerning,
especially with the Food Safety Modernization Act (FSMA) coming into play. The
FDA’s lack of resources will require them to “lean on” the individual states
for cracking down on noncompliance.

The FDA does want to come to some positive conclusion. A
potential change would be for the FDA to start identifying those who are good
players when it comes to GMPs.

InstantGMP was founded on the mission of making GMP
compliance possible for manufacturers of dietary supplements, pharmaceuticals,
medical devices, CBD/hemp, and e-liquids. Our cloud-based software solutions
assist with creating the workflows needed for cGMP compliance and simplifying
electronic batch records.

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