Guidance Advises Generics Makers on Impurities in Drug Substances

A final guidance for generic-drug makers revises recommendations on what chemistry, manufacturing and controls information on drug substances produced by synthesis should be included in ANDAs, drug master files and ANDA supplements.

Drugmakers should include a list of impurities in specifications for a drug substance and describe acceptance criteria for them in their submissions, according to the guidance.

Stability studies, chemical development studies and routine batch analyses can help predict likely impurities in a commercial product, it adds.
Drug GMP Report