Product quality reviews
Article 8
1. Product quality reviews shall be conducted and documented annually for each active substance, taking into account previous reviews and shall include at least a review of the following elements: (a) critical in-process controls and critical active substance test results; (b) all batches that failed to meet established specifications; (c) all critical deviations or non-conformities and the investigation thereof; (d) all changes carried out to the manufacturing process or analytical methods; (e) the results of the stability monitoring programme; (f) all quality-related returns, complaints and recalls; (g) adequacy of corrective actions. 2. The results of the product quality review shall be evaluated and it shall be assessed whether corrective and/or preventive actions are required. Reasons for corrective actions shall be documented and agreed corrective actions shall be completed in a timely and effective manner.