General requirements for quality control
Article 33
1. A quality control department independent from other departments shall be established and maintained. 2. The quality control department shall be allocated adequate resources, including regarding personnel, premises and equipment, to ensure that quality control can be effectively carried out having regard to the nature and size of the manufacturing operations. 3. The quality control department shall ensure that relevant tests are carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory. The quality control department is at least responsible for the following: (a) establishing, validating and implementing quality control procedures; (b) overseeing the control of the reference and retention samples of materials and products, where applicable; (c) ensuring the correct labelling of containers of materials and products; (d) ensuring the monitoring of the stability of the products; (e) participating in the investigation of complaints related to the quality of the product. All the activities referred to in the first subparagraph, points (a) to (e) shall be carried out in accordance with written procedures and, where necessary, recorded. 4. The head of quality control supervises all quality control procedures. In particular, it shall be responsible for the following tasks: (a) approval of specifications, sampling instructions, test methods and other quality control procedures; (b) ensuring that required testing is carried out and the associated records evaluated; (c) ensuring that the appropriate validations are done; (d) approval or rejection of materials used in production, intermediate products, bulk products and finished products; (e) ensuring the qualification and maintenance of the premises and equipment used for quality control; (f) approval and monitoring of any contract analysts. 5. Personnel involved in quality control shall have access to production areas and to all documents that are needed for the assessment of quality control, including: (a) specifications; (b) procedures describing sampling and testing; (c) testing reports and certificates of analysis; (d) procedures for calibration and qualification of instruments and maintenance of equipment and relevant records; (e) validation records of test methods, where applicable; (f) environmental monitoring data for air, water and other utilities, where required; (g) procedures for the investigation of out of specification and out of trend results. 6. Relevant quality control data, such as tests results, yields and environmental data, shall be assessed in a manner permitting trend evaluation. In the case of out of specifications or significant atypical trends, their possible impact on the batches on the market shall be assessed. Where following that assessment it is concluded that the quality of the marketed veterinary medicinal product may be impacted or that shortages of supply can be expected, the competent authorities shall be informed. 7. A quality control check shall be conducted before a finished veterinary medicinal product is released for sale or distribution. That check shall cover all relevant factors, including production conditions, results of in-process testing, a review of manufacturing (including packaging) documentation, compliance with the finished product specifications and examination of the final finished pack. 8. Quality control activities can be outsourced provided that the requirements set out in Article 43 are respected. Where tests on materials used in the manufacture of the veterinary medicinal products are outsourced, audits shall be performed by the manufacturer or via a third party to ensure compliance with relevant requirements of good manufacturing practice and the specifications or methods provided.