PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – SAMPEL REFERENSI DAN PERTINGGAL NO VERSI ASLI VERSI TERJEMAHAN 48 For radiopharmaceuticals sufficient samples of each batch of bulk formulated product should be retained for at least six months after expiry of the finished medicinal product…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PENGAWASAN MUTU NO VERSI ASLI VERSI TERJEMAHAN 39 Some radiopharmaceuticals may have to be distributed and used on the basis of an assessment of batch documentation and before all chemical and microbiology tests have been completed.

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PRODUKSI NO VERSI ASLI VERSI TERJEMAHAN 34 Production of different radioactive products in the same working area (i.e. hot-cell, LAF unit), at the same time should be avoided in order to minimise the risk of cross-contamination…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – DOKUMENTASI NO VERSI ASLI VERSI TERJEMAHAN 29 All documents related to the manufacture of radiopharmaceuticals should be prepared, reviewed, approved and distributed according to written procedures. Semua dokumen yang terkait dengan pembuatan radiofarmaka harus…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – BANGUNAN DAN PERALATAN (PRODUKSI STERIL) NO VERSI ASLI VERSI TERJEMAHAN 25 Sterile radiopharmaceuticals may be divided into those, which are manufactured aseptically, and those, which are terminally sterilised. The facility should maintain the appropriate level of…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – BANGUNAN DAN PERALATAN (UMUM) NO VERSI ASLI VERSI TERJEMAHAN 16 Radioactive products should be manufactured in controlled (environmental and radioactive) areas. All manufacturing steps should take place in self-contained facilities dedicated to radiopharmaceuticals. Produk…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PERSONALIA NO VERSI ASLI VERSI TERJEMAHAN 13 All manufacturing operations should be carried out under the responsibility of personnel with additional competence in radiation protection. Personnel involved in production, analytical control and release of radiopharmaceuticals should…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PEMASTIAN MUTU NO VERSI ASLI VERSI TERJEMAHAN 9 Quality assurance is of even greater importance in the manufacture of radiopharmaceuticals because of their particular characteristics, low volumes and in some circumstances the need to administer the…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PENDAHULUAN NO VERSI ASLI VERSI TERJEMAHAN 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…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PRINSIP NO VERSI ASLI VERSI TERJEMAHAN The manufacture of radiopharmaceuticals should be undertaken in accordance with the principles of Good Manufacturing Practice for Medicinal Products Part I and II. This annex specifically addresses some of the…