ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Sections 7 to 10: materials management, production and in-process controls, packaging and labelling, storage and distribution – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 8.5: Control carry-over of residues between successive batches and prevent contamination of intermediates and APIs, especially after purification

What does 8.5 require?

Residual material may carry over into later batches of the same product if adequately controlled (for example residue on micronizer walls, damp crystals in a centrifuge bowl, or incomplete discharge of a vessel), but it should not carry degradants or microbial contamination that would change the established impurity profile. Production should be run so that other materials do not contaminate intermediates or APIs, and extra care should be taken in handling APIs once purified.

Maintained by Gerard Blokdyk

Other controls in Sections 7 to 10: materials management, production and in-process controls, packaging and labelling, storage and distribution – 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.

MCP endpointAll ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients controls