Hygiene
Article 11
1. Detailed hygiene programmes adapted to the different needs within the manufacturing site shall be established. Such programmes shall include procedures relating to the health, hygiene practices and clothing of personnel. Particular attention shall be paid to hygiene measures necessary for the manufacture of sterile and biological preparations. Hygiene procedures shall be strictly followed by every person entering the production and control areas. 2. Personnel shall be offered a medical examination upon recruitment and subsequent health monitoring proportionate to the risks arising from the specific characteristics of the manufactured product and the tasks of the personnel. Personnel shall be encouraged to declare health conditions that can be of relevance to the quality of products to the manufacturer. 3. As far as possible, no person affected by an infectious disease or having open lesions on the exposed surface of the body shall be involved in the manufacture of veterinary medicinal products. 4. Every person entering the manufacturing areas shall wear protective clothing appropriate to the operations to be carried out, which shall be changed when appropriate. The clothing and its quality shall be appropriate for the process and the grade of the working area. It shall be worn in such a way as to protect the operator and the product from the risk of contamination. 5. Direct contact between the operator’s hands and the exposed product as well as with any part of the equipment that comes into contact with the product shall be avoided. 6. Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas shall be prohibited. Any unhygienic practice within the manufacturing area or in any other area where the product might be adversely affected shall also be prohibited. 7. Visitors or untrained personnel shall generally not be taken into the production or quality control areas. If this is unavoidable, visitors or untrained personnel shall be given information in advance, particularly about personal hygiene and the prescribed protective clothing, and they shall be closely supervised.