ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 6.7: Review and approve batch production and laboratory records, including all deviation, investigation and OOS reports, before release; the quality unit reviews critical steps

What does 6.7 require?

Written procedures should govern how batch production and laboratory control records, packaging and labelling included, are reviewed and approved to confirm the batch meets specification before it is released or shipped. For critical process steps, the quality unit should itself review and approve the records before any API batch is released or shipped; records of non-critical steps may be reviewed by qualified production staff or other units under quality-approved procedures. Every deviation, investigation and OOS report should form part of that batch record review ahead of release. The quality unit may delegate release of intermediates to production, except intermediates sent outside the company's control.