ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 11.2: Test each batch of intermediate and API for conformance, establish and periodically compare an impurity profile for each API, and run microbiological tests where microbial quality is specified

What does 11.2 require?

Appropriate laboratory tests should be carried out on every intermediate and API batch to show it meets specification. An impurity profile describing identified and unidentified impurities in a typical batch from a specific controlled process should normally be set for each API, giving identity or a qualitative designation such as retention time, the range observed and classification (inorganic, organic, solvent); profiles are not normally needed for APIs of herbal or animal tissue origin. The profile should be compared at suitable intervals with the regulatory submission or historical data to detect changes from altered raw materials, equipment settings or process. Microbiological tests should be run on each batch where microbial quality is specified. Analytical method validation is dealt with in section 12.