ANDAs: Impurities in Drug Products Setting Acceptance Criteria for Degradation Products
US FDA recommend that the acceptance criterion be set no higher than the qualified level ( Qualification of Degradation Products). In establishing degradation product acceptance criteria, the first critical consideration is whether a degradation product is specified in the United States Pharmacopeia (USP). If there is a monograph in the USP that includes a limit for a specified identified degradation product, we recommend that the acceptance criterion be set no higher than the official compendial limit.
If the level of the degradation product is above the level specified in the USP, we recommend qualification. Then, if appropriate qualification has been achieved, an applicant may wish to petition the USP for revision of the degradation product’s acceptance criterion.
If the acceptance criterion for a specified degradation product does not exist in the USP and this degradation product can be qualified by comparison to the reference listed drug (RLD), the acceptance criterion should be similar to the level observed in the RLD. In other circumstances, the acceptance criterion may need to be set lower than the qualified level to ensure drug product quality. For example, if the level of the significant metabolite impurity is too high, other quality attributes, like potency, could be seriously affected. In this case, we would recommend that the degradation product acceptance criterion be set lower than the qualified level.
FDA recommend that ANDA sponsors develop robust formulations and manufacturing processes that are based on sound state-of-the-art scientific and engineering principles and knowledge.
Although routine manufacturing variations are expected, significant variation in batch-to-batch degradation product levels or an unusually high level of degradation products may indicate that the manufacturing process of the drug product is not adequately controlled or designed.
1.ANDAs: Impurities in Drug Products
2.ANDAs: Impurities in Drug Products:List of the types of degradation products:
3.ANDAs: Impurities in Drug Products: Qualification of Degradation Products
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