Principle
The establishment and maintenance of a satisfactory system of quality assurance and the correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. 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, including hygiene instructions, relevant to their needs.
General
2.1. 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.
2.2. The manufacturer must have an organization chart. People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice.
Key Personnel
2.3. Key Personnel includes the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the release of products the authorized person(s) designated for the purpose. Normally key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other. In large organizations, it may be necessary to delegate some of the functions listed in 2.5., 2.6. and 2.7.
2.4. ...
2.5. The head of the Production Department generally has the following responsibilities:
i. to ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality; ii. to approve the instructions relating to production operations and to ensure their strict implementation;
iii. to ensure that the production records are evaluated and signed by an authorized person before they are sent to the Quality Control Department;
iv. to check the maintenance of his department, premises and equipment;
v. to ensure that the appropriate validations are done;
vi. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.
2.6. The head of the Quality Control Department generally has the following responsibilities:
i. to approve or reject, as he sees fit, starting materials, packaging materials, and intermediate, bulk and finished products;
ii. to evaluate batch records;
iii. to ensure that all necessary testing is carried out;
iv. to approve specifications, sampling instructions, test methods and
other Quality Control procedures;
v. to approve and monitor any contract analysts;
vi. to check the maintenance of his department, premises and equipment;
vii. to ensure that the appropriate validations are done;
viii. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need. Other duties of the Quality Control Department are summarized in Chapter 6.
2.7. The heads of Production and Quality Control generally have some shared, or jointly exercised, responsibilities relating to quality. These may include, subject to any national regulations:
- the authorization of written procedures and other documents, including amendments;
- the monitoring and control of the manufacturing environment;
- plant hygiene;
- process validation;
- training;
- the approval and monitoring of suppliers of materials;
- the approval and monitoring of contract manufacturers;
- the designation and monitoring of storage conditions for materials and products;
- the retention of records;
- the monitoring of compliance with the requirements of GMP;
- the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
Training
2.8. The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.
2.9. 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 programs should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.
2.10. Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitizing materials are handled, should be given specific training.
2.11. Visitors or untrained personnel should, preferably, not be taken into the production and Quality Control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.
2.12. The concept of Quality Assurance and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.
Personal Hygiene
2.13. Detailed hygiene programs should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programs should be promoted by management and widely discussed during training sessions.
2.14. All personnel should receive medical examination upon recruitment. It must be the manufacturer's responsibility that there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the manufacturer's knowledge. After the first medical examination, examinations should be carried out when necessary for the work and personal health.
2.15. Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products.
2.16. Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.
2.17. Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited. In general, any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected, should be forbidden.
2.18. Direct contact should be avoided between the operator's hands and the exposed product as well as with any part of the equipment that comes into contact with the products.
2.19. Personnel should be instructed to use the hand-washing facilities.
2.20. Any specific requirements for the manufacture of special groups of products, for example sterile preparations, are covered in the Supplementary Guidelines.
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