ICH Q7 Good manufacturing practice for active pharmaceutical ingredients - Scientific guideline
Table of contents
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
- ICH Q7 Q&As Step 4 presentation (see Q7 Q&As Step 4 presentation under Q7 Good Manufacturing Practice: Q7 Q&As Questions and answers: WG Presentations / Trainings)
- E-learning module on ICH Q7