General requirements for personnel
1. At each manufacturing site there shall be a 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. Key personnel, including the qualified persons referred to in Article 97 of Regulation (EU) 2019/6, the head of production, the head of quality control and, where applicable, the head of quality assurance or the head of the quality unit shall be appointed by senior management. They shall be given sufficient resources to fulfil their duties.
3. The duties of the key personnel shall be clearly defined in job descriptions. The hierarchical relationships shall be set out in an organisation chart. There shall be no gaps or unexplained overlaps. The head of production shall assume responsibility for the activities set out in Chapter VI, as well as for the training of personnel and the qualification and maintenance of equipment and premises used for production. The head of quality control shall be responsible for the quality control operations set out in and for the training of personnel.
4. The heads of production and quality control shall be independent from each other. In large organisations, it may be necessary to delegate some of their tasks. However, such delegation of tasks shall not imply a delegation of responsibility. Additionally, depending on the size and organisational structure of the company, a separate head of quality assurance or head of the quality unit may be appointed. In that case, the responsibilities of the heads of production and quality control may be shared with the head of quality assurance or the head of the quality unit.
5. 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 consultants shall be kept.
Training
1. All personnel shall receive initial and continuous training relevant to the tasks assigned. Training on the pharmaceutical quality system and good manufacturing practice shall be provided for personnel whose duties take them into production and storage areas or into control laboratories, and for other personnel whose activities may have an impact on the quality of the product. 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 11.
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. 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.
