General requirements for production
Article 26
1. Manufacturing operations (including packaging operations) and controls shall follow clearly defined procedures designed to ensure the quality of the product and compliance with the requirements set in the relevant manufacturing authorisation and marketing authorisation. 2. Manufacturing steps that may have an impact on the quality or reproducibility of the production, including significant changes thereto, shall be validated. Periodic re-validation shall be required to ensure that such manufacturing processes remain capable of achieving the intended results. Process validation shall comply with the requirements laid down in Annex V. 3. Manufacturing processes shall be duly documented and reviewed regularly, and they shall be improved as appropriate. The effects of changes to the manufacturing process on the quality of the finished product and in relation to the need to ensure consistent production shall be considered prior to the implementation of any changes. No change from the specifications and processes described in the dossier supporting the marketing authorisation shall be implemented before the relevant approval is obtained from the competent authorities, with the exception of variations not requiring assessment in accordance with Article 61 of Regulation (EU) 2019/6. 4. Adequate and sufficient resources shall be made available for the in-process controls. 5. Any deviation from instructions or procedures shall be avoided as far as possible. If a deviation occurs, it shall be approved in writing by a responsible person after having assessed the impact thereof on quality, safety and efficacy with the involvement of the qualified person as appropriate. Deviations shall be investigated to identify the root cause and to implement corrective and preventive measures as appropriate. 6. The manufacturer shall report to the marketing authorisation holder any constraints in manufacturing operations that may result in an abnormal restriction in the supply of the veterinary medicinal product.