The Current Good Manufacturing Practice (CGMP) regulations address component sampling and testing primarily at 21 CFR 211.84. These regulations require representative samples of each shipment of each lot of active and inactive component (or raw materials) to be tested to the identity of the component as labeled prior to release for use in drug product manufacturing. The regulations acknowledge that more than one test may be needed to ascertain a component’s
identity. For the purpose of this answer, a component’s identity is its chemical structure and its physical form (e.g., polymorph, solvate, and appearance) including, if appropriate, its stereochemistry or immunochemistry. (See also ICH Q6A5 and Q6B6 )
The CGMP regulations do not specify the number of containers to be sampled each received shipment. However, 21 CFR 211.84(b) establishes the principles to be followed in designing a sampling program for components. The requirements of this section can be summarized as follows:
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samples are to be representative of the shipment received;
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the number of containers sampled as well as the amount of material sampled each
container is to be based on statistical criteria for component variability, confidence levels, and
the degree of precision required;
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the sample program takes into ac the past quality history of the supplier; and,
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the sample amount is to be sufficient for the necessary analysis and reserve samples.
