Regarding raw material testing, Section 19.4 states “Raw materials used in production of APIs for use in clinical trials should be evaluated by testing, or received with a supplier’s analysis and subjected to identity testing. When a material is considered hazardous, a supplier’s analysis should suffice”. In early phases of development there may be minimal testing in addition to identity. As the process becomes better defined during development, it is typical to identify critical raw material factors and test for them.
