ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 2.2: Keep the quality unit involved in every quality matter and assign it, in writing and without delegation, the core release, approval and oversight responsibilities

What does 2.2 require?

The quality unit should take part in all quality-related matters and review and approve the relevant quality documents. Its main responsibilities should be written down and not handed to others, and should include at least: releasing or rejecting every API, and every intermediate that leaves the company's control; running a release and rejection system for incoming raw materials, intermediates and packing and label stock; reviewing completed batch production and laboratory records of critical steps before an API is distributed; seeing that critical deviations are investigated and closed; approving specifications, master production instructions and every procedure affecting quality; seeing that internal audits happen; approving contract manufacturers of intermediates and APIs; approving changes that could affect quality; signing off validation protocols and their reports; seeing that quality complaints are investigated and closed; seeing that critical equipment is maintained and calibrated under effective systems; seeing that materials are properly tested and results reported; seeing that stability data back up assigned retest or expiry dating and storage conditions; and carrying out product quality reviews.