ICH Q7 Good manufacturing practice for active pharmaceutical ingredients - Scientific guideline

This document provides guidance on the good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It also aims to help ensure that APIs meet the requirements for quality and purity.

Keywords: Good manufacturing practice, active pharmaceutical ingredients (APIs), quality

Current effective version

ICH: Q 7: Good manufacturing practice for active pharmaceutical ingredients - Step 5

Adopted Reference Number: CPMP/ICH/4106/00 Legal effective date: 01/11/2000