ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 19.4-19.5: Evaluate raw materials for clinical APIs by testing or supplier analysis with identity testing, and document production in notebooks or batch records

What does 19.4-19.5 require?

Raw materials for clinical trial APIs should either be tested or arrive with a supplier's analysis and then receive an identity test; for hazardous materials a supplier's analysis is enough. Suitability can sometimes be shown before use by acceptability in small-scale reactions rather than analysis alone. Production should be written up in lab notebooks, batch records or another suitable form, covering the materials and equipment used, the processing and the scientific observations. Yields may vary more than in commercial processes and yield variations need not be investigated.