40. Most radiopharmaceuticals are intended for use within a short New clause, but comments are identical in intent None Nil time and the period of validity with regard to the radioactive shelf-life, to those on ongoing stability in PE009-8 clauses must be clearly stated. 6.23-6.33 41. Radiopharmaceuticals having radionuclides with long New clause no equivalent in PE009-8 No change, it is Nil. – should be tested to show, that they meet all relevant acceptance TGA policy to criteria before release and certification by the Authorised Person. expect testing in accordance with the release specification to release. No impact on existing manufacturers; however, TGA should define half-life” “long 42. Before testing is performed samples can be stored to allow New clause no equivalent in PE009-8 This clause Nil – sufficient radioactivity decay. All tests including the sterility test should clarifies current be performed as soon as possible. practices. No change for industry. 43. A written procedure detailing the assessment of production and New clause, but comments are identical in intent None Nil analytical data, which should be considered before the batch is to those on release in PE009-8 clause 4.24. dispatched, should be established. Complements Annex 3clause 39
40. Most radiopharmaceuticals are intended for use within a short time and the period of validity with regard to the radioactive shelf-life, must be clearly stated. New clause, but comments are identical in intent to those on ongoing stability in PE009-8 clauses 6.23-6.33 None Nil 41. Radiopharmaceuticals having radionuclides with long should be tested to show, that they meet all relevant acceptance criteria before release and certification by the Authorised Person. New clause – no equivalent in PE009-8 No change, it is TGA policy to expect testing in accordance with the release specification to release. No impact on existing manufacturers; however, TGA should define “long half-life” Nil. 42. Before testing is performed samples can be stored to allow sufficient radioactivity decay. All tests including the sterility test should be performed as soon as possible. New clause – no equivalent in PE009-8 This clause clarifies current practices. No change for industry. Nil 43. A written procedure detailing the assessment of production and analytical data, which should be considered before the batch is dispatched, should be established. New clause, but comments are identical in intent to those on release in PE009-8 clause 4.24. Complements Annex 3clause 39 None Nil
consult-manuf-automatic-adoption-pics-130529-comparison.docx