cGMP (Good Manufacturing Practices) Compliance: The Vital Quality Pillar for Dietary Supplements

Regulatory compliance in the dietary supplement industry can be daunting for emerging manufacturers. With over 1500 inspections conducted by the FDA  last year (2024), the need for guidance and support is evident.

To find a specific FDA 483 observational report, one must file a FOI (Freedom of Information Act request for the particular company.  Good Luck with that. I know entities that are still waiting after 12 months for the documents.  The most important thing is to avoid this most unpleasant occurrence.  If you are issued a Form 483, you have 15 days to respond with your remediations for the observed deficiencies; failure to do so can lead to further regulatory actions and potential business disruptions.

The critical part is that if you are a manufacturer and FDA personnel show up for an audit/inspection, it could be harrowing even if you think you have all the bases covered by the cGMP  CFR 21 part 111  section.

Let’s look at the issues most likely to be identified as deficient in the operation.

 Incomplete Product Specifications.  From the Observational FDA 483:

CFR Part 111; Subpart E

“Product specifications for the identity, purity, strength, and composition of the finished dietary supplement were not established.”

The Product Specification for every product you manufacture must contain the following:

All the components are used to manufacture the finished product.  This means the individual ingredients and the packaging components specifications, i.e., jars, lids, dessicants, etc.

The specifications and methodology of the finished product testing, ingredient identity and quantitative analysis for leading actives in the formulation, the specific microbiological testing, and product shelf life data.

The Label Claims for the Ingredient Formula.

 Insufficient or absent Identity testing for the Raw Materials.

A COA (Certificate of Analysis) supplied by the raw material manufacturer is insufficient.  How do we know that this ingredient is the one specified on the COA?

Identity testing is performed by an outside lab with the standards to match it or not.. This happens. I’ve seen it more than once or twice.

Environmental controls, i.e., preventing biological contamination.

Logs of the actual monitoring of surfaces & equipment must be completed at the time of Performance. Deviations or failures indicated the monitoring devices must be documented and rectified before any production can commence.

#4 cGMP Training.

A log must be kept, and procedures must be implemented for periodic employee training. This is crucial for ensuring all employees know the latest regulatory updates and best practices.

Nutrition 50 can help by:

• Performing  an audit and identifying the gaps (Gap Analysis).

• Writing the necessary Standard Operating Procedures (SOPs), creating the Flow Charts, and writing the cGMP Training Protocols.

• It can be accomplished over a structured timeframe and at a very reasonable cost.

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