General requirements for premises
Article 12
1. Premises used for the manufacture or import of veterinary medicinal products shall be suitable for the intended operations. In particular, the premises shall be designed or adapted, equipped, operated, cleaned and maintained to minimise the opportunity for extraneous contamination, cross-contamination, the risk of errors and any adverse effect on the quality of the products. 2. Premises shall be designed and equipped so as to afford maximum protection against the entry of insects or other animals. Measures to prevent the entry of unauthorised people shall be implemented. 3. Production, storage and quality control areas shall not be used as a right of way by personnel not working in those areas.