ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 3.1: Staff manufacture with enough qualified people, written responsibilities and regular, recorded, periodically assessed GMP training

What does 3.1 require?

There should be enough staff with suitable education, training or experience to carry out and oversee the making of APIs and intermediates, and each person's responsibilities should be set out in writing. Qualified people should give training regularly, covering at least the tasks the employee does and the GMP that applies to that job; training should be recorded and its effectiveness periodically assessed.