(1993; 36 pages)
3.1 The manufacturing establishment and its personnel shall be under the authority of a person who has been trained in the techniques used in manufacturing biological substances and who possesses the scientific knowledge upon which the manufacture of these products is based. The personnel shall include specialists with training appropriate to the products made in the establishment.
3.2 Personnel required to work in clean and aseptic areas should be selected with care, to ensure that they may be relied upon to observe the appropriate codes of practice and are not subject to any disease or condition that could compromise the integrity of the product microbiologically or otherwise. High standards of personal hygiene and cleanliness are essential. Staff should be instructed to report any conditions (e.g. diarrhoea, coughs, colds, infected skin or hair, wounds, fever of unknown origin) that may cause the shedding of abnormal numbers or types of organisms into the working environment. Health checks on personnel for such conditions should be required before employment and periodically thereafter. Any changes in health status that could adversely affect the quality of the product shall preclude the person concerned from working in the production area.
3.3 Only the minimum number of personnel required should be present in clean and aseptic areas when work is in progress. Inspection and control procedures should be conducted from outside these areas as far as possible.
3.4 During the working day, personnel shall not pass from areas where live microorganisms or animals are handled to premises where other products or organisms are handled unless clearly defined decontamination measures, including a change of clothing and shoes, are followed. Persons not concerned with the production process should not enter the production area except for essential purposes, and in that case they shall be supplied with sterile protective clothing.
3.5 The staff engaged in the manufacturing process should be separate from the staff responsible for animal care.
3.6 The names and qualifications of those responsible for approving lot processing records (protocols) should be registered with the national control authority.
3.7 To ensure the manufacture of high-quality products, personnel should be trained in good manufacturing and laboratory practices in appropriate fields such as bacteriology, virology, biometry, chemistry, medicine, immunology and veterinary medicine.
3.8 Training records should be maintained and periodic assessments of the effectiveness of training programmes should be made.
3.9 All personnel engaged in production, maintenance, testing and animal care (and inspectors) should be vaccinated with appropriate vaccines and, where appropriate, be submitted to regular testing for evidence of active tuberculosis. Apart from the obvious problem of exposure of staff to infectious agents, potent toxins or allergens, it is necessary to avoid the risk of contamination of a production batch with these agents.
3.10 Where BCG vaccines are being manufactured, access to production areas shall be restricted to staff who are carefully monitored by regular health checks. In the case of manufacture of products derived from human blood or plasma, vaccination of workers against hepatitis B is recommended.