(2003; 148 pages)
8. Quality assurance and quality control
8.1 Radiopharmaceuticals are nearly always used before all quality control testing (e.g. tests for sterility, endotoxin, radionuclidic purity, etc.) has been completed. The implementation of and compliance with the quality assurance programme are therefore essential.
8.2 Quality assurance and/or quality control should have the following principal responsibilities:
(a) the preparation of detailed instructions for each test and analysis;
(b) ensuring the adequate identification and segregation of test samples to avoid mix-ups and cross-contamination;
(c) ensuring that environmental monitoring and equipment and process validation are conducted as appropriate for evaluating the adequacy of the manufacturing conditions;
(d) the release or rejection of starting materials and intermediate products;
(e) the release or rejection of packaging and labelling materials;
(f) the release or rejection of each batch of finished preparation;
(g) the evaluation of the adequacy of the conditions under which the starting materials, intermediate products and finished radiopharmaceutical preparations are stored;
(h) the evaluation of the quality and stability of the finished products and, when necessary, of the starting materials and intermediate products;
(i) the establishment of expiry dates on the basis of the validity period related to specified storage conditions;
(j) the establishment and revision of the control procedures and specifications;
(k) assuming the responsibility for retaining samples of radiopharmaceutical products;
(l) assuming the responsibility for keeping adequate records of the distribution of the radiopharmaceutical products.
8.3 Whenever the size of the establishment permits, quality assurance and quality control duties should be organized in separate groups. Quality assurance should also include the monitoring and validation of the production process.
8.4 A manufacturer’s quality control laboratory should be separated from the production area. The control laboratory should be designed, equipped and of such a size as to be a self-contained entity, with adequate provision for the storage of documents and samples, the preparation of records and the performance of the necessary tests.
8.5 The performance of all qualitative and quantitative tests mentioned in the specifications for the starting materials may be replaced by a system of certificates issued by the supplier of these materials, provided that:
(a) there is a history of reliable production;
(b) the producer or supplier is regularly audited;
(c) at least one specific identity test is conducted by the manufacturer of the finished radiopharmaceutical.
8.6 Samples of the intermediate and final products should be retained in sufficient amounts and under appropriate storage conditions to allow repeated testing or verification of a batch control. These samples should be kept for an appropriate period in accordance with the shelf-lives of the radioactive components concerned. However, this may sometimes not be applicable, e.g. for radiopharmaceuticals with a short half-life.
8.7 Sampling procedures may be adapted to the purpose of the sampling, the type of controls being applied, and the nature of the material being sampled (e.g. a small batch size and/or its radioactive content). The procedure should be described in a written protocol.