General requirements for personnel
1. At each manufacturing site there shall be sufficient number of personnel with the necessary qualifications and practical experience having regard to the intended operations. The individual responsibilities of personnel shall be clearly laid out.
2. Consultants shall have adequate education, training, and experience to advise on the subject for which they are retained. Records of the qualifications and type of service provided by the consultants shall be kept.
Training
1. All personnel shall receive initial and continuous training relevant to the tasks assigned. Training on the quality management system and good manufacturing practice shall be provided for personnel whose duties take them into production and storage areas or into control laboratories. Personnel working in areas where contamination is a hazard, such as clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, shall be given specific training. Training shall also include the hygiene programmes referred to in Article 12.
2. The practical effectiveness of training shall be periodically assessed. Records of the trainings shall be kept.
Hygiene
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. Persons affected by an infectious disease or having open lesions on the exposed surface of the body shall not be involved in activities that could result in compromising the safety or quality of the active substances.
3. 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 product from the risk of contamination.
4. Direct contact between the operator and the exposed product as well as with any part of the equipment that comes into contact with the products shall be avoided.
5. Eating, drinking, chewing or smoking, or the storage of food, drinks, smoking materials in the production and storage areas shall be prohibited.
