The GMP Compliance Conundrum

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The GMP Compliance Conundrum

The acting deputy director of the Division of Dietary Supplements 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 wanting to learn good manufacturing practices, read and apply the GMPs for dietary supplements. Otherwise, you are at risk of receiving a Warning Letter.

  • Larger firms are not receiving Warning Letters because they have the resources to interpret the FDA, but smaller firms generally
    do not. The FDA has no comprehensive GMP compliance guidelines for dietary supplement manufacturing. Specifications, as example, are the biggest issue when it comes to non-compliance, 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 documentation, and providing other valuable information.

The FDA’s focus is enforcement, not assistance. It brings up the question of how a company can meet requirements if no information is available on how to meet requirements. The go-to response has been to read the preamble simply. 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 who 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 a stretched-thin agency. 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.

With the Dietary Supplement Health and Education Act of 1994 (DSHHEA), the FDA can’t police the industry, given
the incredible amount of products on the market. An estimated 80,000 supplements are 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 to crack 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 to make 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.