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 3.2: Enforce personnel hygiene: suitable clean clothing and protective wear, no direct contact with product, food and smoking kept to set areas, and exclusion of ill workers

What does 3.2 require?

Staff should keep good hygiene and health habits and wear clean clothing suited to their work, changed when needed, plus head, face, hand and arm protection where required to protect product from contamination. They should avoid touching intermediates or APIs directly. Smoking, eating, drinking, chewing and keeping food should be limited to designated areas away from manufacturing. Anyone with an infectious disease or open lesions on exposed skin should not do work that could compromise API quality, and anyone found at any time (by medical check or supervisor observation) to be ill or to have open lesions should be kept away from such work until the condition clears or a qualified medical person decides they can safely return.

Maintained by Gerard Blokdyk

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

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