ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 7.1: Govern materials under written procedures and buy critical materials against agreed specifications from quality-approved suppliers whose actual manufacturer is known

What does 7.1 require?

Written procedures should cover how materials are received, identified, quarantined, stored, handled, sampled, tested and then approved or rejected. Manufacturers should have a system for evaluating suppliers of critical materials and should buy against an agreed specification from suppliers approved by the quality unit. Where a critical material comes from a supplier other than its maker, the manufacturer's name and address should be known. A change of source for critical raw materials should go through change control.