ICH Q7 for APIs: A Step-by-Step, Inspection-Ready Guide from Starting Materials to Release
ICH Q7 for APIs: A Step-by-Step, Inspection-Ready Guide from Starting Materials to Release ICH Q7 for APIs — Step-by-Step, Inspection-Ready Guide ICH Q7 defines Good Manufacturing Practice for active pharmaceutical ingredients (APIs) used in human drug products. The guideline covers chemical synthesis, fermentation, recovery, purification, and—where relevant—post-isolation processing steps such as milling and micronization. While…