PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – GLOSARIUM ANEKS 3

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – GLOSARIUM ANEKS 3 NO VERSI ASLI VERSI TERJEMAHAN Preparation: handling and radiolabelling of kits with radionuclide eluted from generators or radioactive precursors within a hospital. Kits, generators and precursors should have a marketing authorisation or a…

PIC/S BAB II (PERSONALIA) – KONSULTAN

BAB II (PERSONALIA) – KONSULTAN NO VERSI ASLI VERSI TERJEMAHAN 2.21 Consultants should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Konsultan harus memiliki pendidikan, pelatihan, dan pengalaman yang memadai,…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PRODUKSI

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

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) – PENDAHULUAN

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) – PEMASTIAN MUTU

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 1 (PEMBUATAN PRODUK STERIL) – STERILISASI

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – STERILISASI NO VERSI ASLI VERSI TERJEMAHAN 83 All sterilisation processes should be validated. Particular attention should be given when the adopted sterilisation method is not described in the current edition of the European (or other relevant) Pharmacopoeia or when…