Principle
- The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of therapeutic products relies upon people. For this reason there should be sufficient competent personnel to carry out all the tasks in accordance with documented procedures. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training relevant to their needs.
General
- The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.
- The manufacturer should have an organisation chart. Key personnel should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to suitably qualified designated deputies. There should be no gaps or unexplained overlaps in the responsibilities of personnel.
Key personnel
Quality and production nominees
- The responsibility for quality and production should be allocated to persons specified on the manufacturing licence.
- The nominees should be different persons, neither responsible to the other. They should have the authority to ensure that quality measures are employed in the manufacture (including testing) of product.
- The quality and production nominees should have a relevant tertiary level qualification, (e.g. in medicine, science, biological science, medical laboratory science, nursing, pharmacy), and have had practical experience, at management level, in the manufacture of therapeutic products.
- The Production nominee generally has the following responsibilities:
- to ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;
- to approve the procedures relating to production operations and to ensure their strict implementation;
- to ensure that facilities and equipment are maintained;
- to ensure that the appropriate validations are done;
- to ensure that the required initial and continuing training of production personnel is carried out.
- The Quality nominee generally has the following responsibilities:
- to approve or reject, as appropriate, materials and therapeutic products;
- to evaluate process records;
- to ensure that all necessary testing is carried out;
- to approve specifications, sampling instructions, test methods and other quality procedures;
- to approve and monitor any subcontractors and suppliers;
- to ensure the maintenance of the quality department premises and equipment;
- to ensure that the appropriate validations are done;
- to ensure that the required initial and continuing training of the quality personnel is carried out.
Training
- The manufacturer should provide training for all personnel whose duties take them into processing areas or into laboratories, and for other personnel whose activities could affect the quality of the product.
- Beside the basic training on the theory and practice of Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.
- Personnel working in areas where contamination is a hazard, (e.g. clean areas or areas where infectious materials are handled), should be given specific training.
- Visitors or untrained personnel should not be taken into the processing and Quality Control areas. If this is unavoidable, they should be given appropriate information in advance and they should be closely supervised.
Records
- Records should demonstrate that each staff member is trained and competent for the work practices they are authorised to perform.
- Personnel should not be permitted to sign or initial a document unless they have been trained and assessed as competent in the work practices associated with the signature, and in the significance of the signature.
- A register of staff signatures and initials should be established and kept up to date.