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# Impurity Acceptance Criteria MAPP
- URL: https://www.fdaweb.com/impurity-acceptance-criteria-mapp/
- Published: 2018-09-19T12:00:00.000Z
- Updated: 2026-09-15T00:32:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142392

CDER has issued a Manual of Policies and Procedures to provide guiding principles and approaches for establishing drug substance and drug product impurity acceptance criteria for non-mutagenic impurities in NDAs, ANDAs, and BLAs, based on the consideration of clinical relevance. Currently, the [MAPP](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM590073.pdf?ref=fdaweb.com) says, establishment of a drug substance and drug product impurity acceptance criterion can be supported by clinical data, non-clinical data, comparative impurity analysis of the proposed drug product with an FDA approved drug product, analytical precision of the method used to measure the impurity, and manufacturing process capability.

“The intent of this MAPP is to clarify the types of data and information needed as well as the limitations when establishing impurity acceptance criteria,” the document says. “In general, the types of data and information should be guided by the consideration of clinical impact of impurity levels, as opposed to manufacturing process capability, to ensure the acceptance criteria are clinically relevant.”