ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 2.5: Conduct and document a product quality review of each API, normally every year, and act on what it shows

What does 2.5 require?

Each API should have a regular quality review to confirm the process is consistent, normally documented once a year, covering at least: critical in-process control and critical test results; every batch that failed specification; every critical deviation or non-conformance and its investigation; any change to processes or analytical methods; stability monitoring results; every quality-related return, complaint and recall; and whether past corrective actions were adequate. The results should be evaluated to decide whether corrective action or revalidation is needed, the reasons for any corrective action recorded, and agreed actions completed promptly and effectively.