ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Sections 14 to 17: rejection and re-use, complaints and recalls, contract manufacturers, agents, brokers, traders and distributors – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 17.4-17.5: Repack, relabel and hold APIs under GMP controls and suitable environmental conditions, and run stability studies when repacking into a different container type

What does 17.4-17.5 require?

When APIs and intermediates are repacked, relabelled or kept in storage, GMP controls should apply so that they are not mixed up and keep their identity and purity, and repackaging should take place in suitable environmental conditions that avoid contamination and cross-contamination. Where material is repacked into a different type of container from the manufacturer's, stability studies should be done to justify the assigned expiry or retest dates.

Maintained by Gerard Blokdyk

Other controls in Sections 14 to 17: rejection and re-use, complaints and recalls, contract manufacturers, agents, brokers, traders and distributors – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.