Think You Know Dietary Supplement GMPs?
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Master Manufacturing Records must include:
- A list of all components to be used.
- A statement of any intentional overage of an ingredient.
- Instructions for destruction of the batch if necessary.
View Answer
The correct answers are a and b. However, under 21 CFR Part 211.186 there are several more specific requirements for Master Batch records. See that section for the complete list.
Dietary Supplement Component manufacturers:
- May rely on a certificate of analysis (COA) from the supplier for confirming the identity of a dietary ingredient.
- May not rely on COAs for confirming the identity of components that are not dietary ingredients.
- Must conduct at least one appropriate test or examination to verify the identity of a dietary ingredient.
View Answer
The correct answer is c. If the COA from the supplier has been validated the COA can be used to verify the identity of all ingredients other than the dietary ingredient. At least one identity test must always be done for the dietary ingredient.
Dietary supplement microbiological test methods:
- Do not need to be validated or be scientifically valid.
- Need to be scientifically valid.
- Show that the product is sterile.
View Answer
The correct answer is b. Microbiological test methods, just as analytical test methods, must be shown to be scientifically valid.
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