(2003; 148 pages)
3.1 The manufacturing establishment, whether a hospital radiopharmacy, centralized radiopharmacy, nuclear centre or institution, industrial manufacturer or PET centre, and its personnel should be under the control of a person who has a proven record of academic achievement together with a demonstrated level of practical expertise and experience in radiopharmacy and radiation hygiene. Supporting academic and technical personnel should have the necessary postgraduate or technical training and experience appropriate to their function.
3.2 Personnel required to work in radioactive, clean and aseptic areas should be selected with care, to ensure that they can be relied on to observe the appropriate codes of practice and are not subject to any disease or condition that could compromise the integrity of the product. Health checks on personnel should be requested before employment and periodically thereafter. Any changes in personal health status (e.g. in haematology) may require the temporary exclusion of the person from further radiation exposure.
3.3 Only the minimum number of personnel required should be present in clean and aseptic areas when work is in progress. Access to these areas should be restricted during the preparation of radiopharmaceuticals, kits or sterile set-ups. Inspection and control procedures should be conducted from outside these areas as far as possible.
3.4 During the working day, personnel may pass between radioactive and non-radioactive areas only if the safety rules of radiation control (health physics control) are respected.
3.5 The release of a batch may be approved only by a pharmacist or a person with academic qualifications officially registered as a suitably qualified person, and with appropriate experience in the manufacture of radiopharmaceuticals.
3.6 To ensure the safe manufacture of radiopharmaceuticals, personnel should be trained in GMP, the safe handling of radioactive materials and radiation safety procedures. They should also be required to take periodic courses and receive training to keep abreast of the latest developments in their fields.
3.7 Training records should be maintained and periodic assessments of the effectiveness of training programmes should be made.
3.8 All personnel engaged in production, maintenance and testing should follow the relevant guidelines for handling radioactive products and be monitored for possible contamination and/or irradiation exposure.