ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Sections 3 to 5: personnel, buildings and facilities, process equipment and computerised systems – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 3.3: Use only suitably qualified consultants and keep records of their name, address, qualifications and service

What does 3.3 require?

Any consultant who advises on making or controlling APIs or intermediates should hold enough education, training and experience, in any combination, for the subject they advise on. Records should hold each consultant's name, address, qualifications and the type of service given.

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Other controls in Sections 3 to 5: personnel, buildings and facilities, process equipment and computerised systems – 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.