GMP Platform

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GMP Platform

Kami CM Plus Group adalah perusahaan penyedia jasa manajemen profesional dan konsultan yang memiliki keahlian di bidang life science, Engineering sejak perencanaan hingga inspeksi, konsultasi GMP dan Bisnis Internasional. Dengan kantor pusat di Yokohama Jepang, kami tersebar di beberapa negara di Asia lainnya seperti Vietnam, Indonesia, Singapura, Thailand dan Cina.

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 ANEKS 3 (PEMBUATAN RADIOFARMAKA) – DISTRIBUSI

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – DISTRIBUSI NO VERSI ASLI VERSI TERJEMAHAN 51 Distribution of the finished product under controlled conditions, before all appropriate test results are available, is acceptable for radiopharmaceuticals, providing the product is not administered by the receiving institute…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PENGAWASAN MUTU

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

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) – PERSONALIA

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

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…