Drugs

CDER Impurity Acceptance Criteria MAPP

CDER has published a Manual of Policies and Procedures (MAPP) on Assessing Impurity Acceptance Criteria as Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance. “While the ICH guidance for industry Q3A(R2) Impurities in New Drug Substances (June 2008) and the ICH guidance for industry Q3B(R2) Impurities in New Drug Products (August 2006) apply to new drug substances produced by chemical synthesis and new drug products, the principles of these guidances and the principles of this MAPP may apply to other drug substances and drug products, including some semi-synthetic and fermentation products, and peptides, submitted in NDAs and ANDAs,” the MAPP says.

The principles in the MAPP may also apply to:

establishment of acceptance criteria for DNA-reactive impurities that are generally controlled at tighter limits according to the ICH M7(R2) guidance for industry;
investigational drug substances and drug products, depending on the risk; and
enantiomeric (a pair of chemical compounds that are non-superimposable mirror images of each other) impurities where the active ingredient is a single enantiomer.

Excluded from the MAPP are:

residual solvents and elemental impurities;
extraneous contaminants that should not occur in drug substances and drug products and are addressed by current good manufacturing practice requirements;
microbiological attributes; and
leachables from the container closure system.

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