GMP Compliance Series: Part 4: Specifications That Improve Compliance

FDA inspectors noted Oza failed to set specifications for identity, purity, strength and composition for each component used in the manufacturing of its dietary supplement product. Such specifications were also not established for the finished product. The agency reminded the company has to both establish the required specifications and ensure the specifications are met. Another dietary supplement company, Dynamic Pharmaceuticals, Inc., was cited because their finished product testing only included specifications for physical tests, and not for identity, purity, strength, and composition. The FDA warned these firms that failing to make and meet specifications could lead to a regulatory action such as an injunction to halt production.

InstantGMP Compliance Series – Specifications that Improve Compliance from Richard Soltero on Vimeo.

Why specifications are important:

Setting up specifications is necessary to make sure you can verify that your finished product meet your own requirements for identity, purity, strength, composition. This identity specification is necessary to make sure your final product contains the right ingredients or components. The strength specification allows you to calculate the weight or measure of precisely how much of an ingredient or component should be added. Setting up specs for purity or for cleaning and sanitizing equipment before using it is used in a batch can ensure there are no contaminants that will get into the final product. They also can prevent contamination that may lead to adulteration of the finished batch.

How to improve compliance:
You can verify that specs are set for every component and are met by testing or examination. You can ensure each sub-batch and each finished batch of a dietary supplement has specs and that these are tested every time.

Also, specs have to be established for all materials and components used in production, including:

  • Dietary ingredients (when received)
  • In-process production materials
  • Labels
  • Packaging components
  • Finished batch
  • Product received from a supplier for packaging and labeling

You have to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient. You need an identity specification for each component used in a dietary supplement. The specifications for identity may include more than one attribute, for example, a salt might include the physical characteristics (crystal or powder), the color, and the state of hydration. Identity of a botanical may include which part of the plant (e.g., roots or leaves) are used, the color, and whether the part of the plant is in a native state or has been ground up.

You also have to set limits on components that may lead to adulteration of the finished product. If you have equipment that is critical to the process it has to be cleaned and/or sanitized, then tested for cleanliness. If your raw materials come from sources that are exposed to dirt or the atmosphere, you will need specifications and testing methods to ensure that you have eliminated possible microbial contamination that might get into the batch.

In-process specifications will be needed for any point in the manufacturing process where control ensures quality of the final product, for example:

  • Control of temperature where heating or cooling may affect quality
  • Specific sanitation procedures that are needed to protect the product
  • Control points where cross-contamination might occur
  • Where personal or environmental hygiene steps are necessary for quality

Some specifications are not needed for dietary supplements. For example, dissolution, disintegration, and bioavailability are tests where requirements are not needed since these areas of science are still evolving.

All in all, setting specifications and testing to make sure the specifications are met is both required by GMPs and by good common sense when you want to produce uniform, high quality products.

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