well as with other relevant national requirements. [1. The manufacturing and handling of radiopharmaceuticals is New clause in PE009-10 However, this is almost None, the clause Nil potentially hazardous. The level of risk depends in particular upon the identical from the principle in PE009-8: is a types of radiation, the energy of radiation and the half-lives of PRINCIPLE manufacturing and handling “The radioactive isotopes. Particular attention must be paid to the prevention statement. of radiopharmaceuticals is potentially of cross-contamination, to the retention of radionuclide contaminants, hazardous. The types of radiation emitted and and to waste disposal.] the half-lives of the radioactive isotopes are parameters contributing to the level of risk. Particular attention must be paid to the prevention of cross-contamination, to the retention of radionuclide contaminants, and to waste disposal” 2. Due to shelf-life of their radionuclides, some New clause in PE009-10 However, this is almost None, the clause Nil radiopharmaceuticals may be released before completion of all quality identical wording from the principle in PE009-8. is a control tests. In this case, the exact and detailed description of the The term has replaced “shelf-life” “half-life”: whole release procedure including the responsibilities of the involved statement. PRINCIPLE to their short half-life, some “Due personnel and the continuous assessment of the effectiveness of the radiopharmaceuticals are released before quality assurance system is essential. completion of certain Quality Control tests. In this case, the continuous assessment of the effectiveness of the Quality Assurance system becomes very important.” 3. This guideline is applicable to manufacturing procedures employed New clause no equivalent in Providing Nil – by industrial manufacturers, Nuclear Centres/Institutes and PET additional Centres for the production and quality control of the following types of clarification on products: applicability of the GMP Guide to
well as with other relevant national requirements. [1. The manufacturing and handling of radiopharmaceuticals is potentially hazardous. The level of risk depends in particular upon the types of radiation, the energy of radiation and the half-lives of radioactive isotopes. Particular attention must be paid to the prevention of cross-contamination, to the retention of radionuclide contaminants, and to waste disposal.] New clause in PE009-10 However, this is almost identical from the principle in PE009-8: PRINCIPLE “The manufacturing and handling of radiopharmaceuticals is potentially hazardous. The types of radiation emitted and the half-lives of the radioactive isotopes are parameters contributing to the level of risk. Particular attention must be paid to the prevention of cross-contamination, to the retention of radionuclide contaminants, and to waste disposal” None, the clause is a statement. Nil 2. Due to shelf-life of their radionuclides, some radiopharmaceuticals may be released before completion of all quality control tests. In this case, the exact and detailed description of the whole release procedure including the responsibilities of the involved personnel and the continuous assessment of the effectiveness of the quality assurance system is essential. New clause in PE009-10 However, this is almost identical wording from the principle in PE009-8. The term “shelf-life” has replaced “half-life”: PRINCIPLE “Due to their short half-life, some radiopharmaceuticals are released before completion of certain Quality Control tests. In this case, the continuous assessment of the effectiveness of the Quality Assurance system becomes very important.” None, the clause is a statement. Nil 3. This guideline is applicable to manufacturing procedures employed by industrial manufacturers, Nuclear Centres/Institutes and PET Centres for the production and quality control of the following types of products: New clause – no equivalent in Providing additional clarification on applicability of the GMP Guide to Nil
consult-manuf-automatic-adoption-pics-130529-comparison.docx