Production areas
Article 13
1. Cross-contamination shall be prevented by the appropriate design and operation of the premises. The measures to prevent cross-contamination shall be commensurate with the risks. Quality risk management principles shall be used to assess and control the risks. 2. Depending on the level of risk and based on the outcome of a quality risk management assessment, it may be necessary to dedicate premises and equipment for manufacturing or packaging operations to a particular product or product class. Dedicated premises shall be required when a risk cannot be adequately controlled by operational or technical measures. 3. The layout of the premises shall permit the production to take place in areas connected in a logical order corresponding to the sequence of the operations and the required level of cleanliness. 4. The arrangement of the working and in-process storage space shall be adequate to minimise the risk of confusion between different products or their components, to avoid cross-contamination, and to minimise the risk of omission or the wrong application of any of the manufacturing or control steps. 5. Where the materials used in the production of a veterinary medicinal product, an intermediate product or bulk product are exposed to the environment, the interior surfaces of the area (walls, floors and ceilings) shall be smooth, free from cracks and open joints, shall not shed particulate matter, and shall permit easy and effective cleaning and, if necessary, disinfection. 6. Pipework, light fittings, ventilation points and other services shall be designed and sited so as to avoid the creation of recesses that are difficult to clean. As far as possible, for maintenance purposes, they shall be accessible from outside the manufacturing areas. 7. Drains shall be of adequate size and have trapped gullies. Open channels shall be avoided where possible but, where they are necessary, they shall be shallow to facilitate cleaning and disinfection. 8. Production areas shall be effectively ventilated, with air control facilities (including temperature and, where necessary, humidity and filtration) appropriate to the products handled, to the operations undertaken within them, and to the external environment. 9. In cases where dust is generated, such as during sampling, weighing, mixing and processing operations, or packaging of dry products, specific measures shall be implemented to avoid cross-contamination and to facilitate cleaning.