Product quality reviews
Article 6
1. Product quality reviews shall be conducted and documented annually for each veterinary medicinal product, taking into account previous reviews, and shall include at least a review of the following elements: (a) materials used in the manufacturing process, especially those from new sources; (b) the supply chain traceability of active substances; (c) critical in-process controls and finished product results; (d) all batches that failed to meet established specification(s) and the investigation thereof; (e) significant deviations or non-conformances, the investigation thereof, and the effectiveness of resultant corrective and preventive actions taken; (f) changes carried out to the manufacturing process or analytical methods; (g) variations to the terms of the marketing authorisation affecting quality that have been submitted, granted or refused, as well as a review of post-marketing obligations affecting quality, including those relevant for veterinary medicinal products intended only for export; (h) the results of the stability monitoring programme and any adverse trends; (i) quality-related returns, complaints and recalls and the investigations performed at the time; (j) adequacy of any other previous product, process or equipment corrective actions; (k) the qualification status of relevant equipment and utilities, such as HVAC, water or compressed gases; (l) any contractual arrangements for outsourced activities to ensure that they are up to date. 2. Procedures shall be set for the conduct and evaluation of the product quality reviews and the effectiveness thereof shall be verified during the self-inspections referred to in Article 7. Product quality reviews may be grouped by product type (e.g. solid dosage forms, liquid dosage forms, sterile products), where scientifically justified. 3. The results of the product quality review shall be evaluated and it shall be assessed whether corrective and/or preventive actions or any revalidation is required. Where appropriate, opportunities for quality improvements shall be considered.