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 17.6: Pass all quality and regulatory information between the manufacturer and the customer, name the original manufacturer and batch, disclose the manufacturer to authorities on request and meet the certificate of analysis rules

What does 17.6 require?

Agents, brokers, distributors, repackers and relabellers should pass every piece of quality or regulatory information in both directions, from the API or intermediate maker to the customer and back again. Whoever supplies the customer should give the original manufacturer's name and the batch numbers supplied. The agent should also identify the original manufacturer to regulators on request (the manufacturer may respond to the authority directly or through its authorised agents). Certificates of analysis should follow section 11.4.

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.