GMP Compliance Series – Part 13: Testing in Dietary Supplement Manufacturing

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GMP Compliance Series – Part 13: Testing in Dietary Supplement Manufacturing

GMP Problems:

The FDA inspects dietary supplement manufacturers to ensure they are in cGMP compliance. After they inspected Sterling USA Neutraceutical Lab they cited them for failing to conduct at least one test or examination that would verify the identity the dietary ingredients used in their products. Testing each dietary ingredient prior to its use is required by 21 CFR 11. If they do not promptly correct the violations enumerated in the warning letter, the FDA could start enforcement action without further notice. Enforcement action may include seizure of the cited products and/or injunction against the manufacturers and distributors of these products.

Why testing is important:

There are many GMP requirements for tests and specifications for dietary supplement products. The attributes of a product are tested to show that the product is potent, it has the right strength, it has the proper composition according to its label and that is free from impurities or adulteration. These are important to guarantee the quality of the final product. Proof of these attributes is what the consumer must rely on so they are sure that the product will be useful and not harmful to their health. Testing is what provides the proof.

How to improve:

GMP regulations require tests and specifications for components, in-process production, labels and packaging, the finished batch of dietary supplement, product received from a supplier for packaging and labeling, and the packaging and labeling for the finished packaged and labeled dietary supplement. There must be tests and specifications necessary to prevent adulteration as a result of manufacturing operation and not as a result of contaminants from the components. For example, a certain piece of equipment might have to be cleaned or sanitized after handling certain raw materials that might have microbial contamination.

Product specifications are identity, purity, strength, and composition and the limits for possible contaminants for a finished batch of dietary supplement. The identity specification is especially important to ensure that the finished dietary supplement has the right composition. Many dietary supplements contain a variety of ingredients especially if they come from a natural source so you could not know what your final product contains if you do not know what you put into it.

The FDA requires that each incoming dietary ingredient is tested or examined for identity. It is up to each firm to decide which test is scientifically valid. It may be a gross organoleptic analysis, a macroscopic analysis, a microscopic analysis or a chemical analysis. In any event, firms may not use a certificate of analysis from the supplier. An organoleptic analysis may be appropriate for whole or coarsely-cut botanical parts, however it may not be appropriate for powdered or extracted botanicals because processing may change their odor.

The incoming test for vitamins or minerals might include a combination of various tests, for example:

  • Identification
  • Assay
  • Appearance
  • Odor
  • Solubility
  • Melting Point
  • Loss on Drying or Residue on Ignition
  • Heavy Metals
  • Organic Volatile Impurities

No specifications have to be set for the identity, purity, strength, or composition of the various constituents that are inherently present in a natural product such as a botanical. However, the identity of the botanical has to be confirmed. This could include establishing the identity of the part of the plant used and the color and the odor. A comparison to an authentic representative plant will be useful here.

Testing and Release of Final Product is the sponsor’s responsibility. Samples are pulled from the production batch and submitted to Quality Control. QC will test the product in accordance with the tests in the specifications. The Quality group will disposition the batch after the final product is tested. If you receive a product from a supplier for packaging or labeling, you must test to ensure that the product received is consistent with your purchase order.

Some specifications are not needed for dietary supplements. For example, the aesthetic appearance of a dietary supplement does not need to be evaluated. Tests for dissolution, disintegration, and bioavailability of dietary supplements are examples of areas where scientific study is still evolving and it is premature to impose requirements for these tests. For botanicals, there are a variety of constituents that are normally present in a natural product so specifications are not needed for these.

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