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PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B2. PRODUK ALERGEN

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B2. PRODUK ALERGEN NO VERSI ASLI VERSI TERJEMAHAN Materials may be manufactured by extraction from natural sources or manufactured by recombinant DNA technology. Bahan dapat dibuat dengan ekstraksi…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PRINSIP

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PRINSIP NO VERSI ASLI VERSI TERJEMAHAN The manufacture of sterile products is subject to special requirements in order to minimise risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of…

{SPECIAL ARTICLE} PHARMACOVIGILANCE OVERVIEW IN INDONESIA

Even though that the history of pharmacovigilance started in the end 1950s (or early 1960s) after Thalidomide tragedy, the mechanism of pharmacovigilance established after years later. The usage of “Yellow Card scheme” was first developed in England in 1964 as a response for Thalidomide tragedy, to collect necessary…

Rekomendasi FDA: Pelaksanaan uji non klinis untuk obat diagnostic radiofarmaka dosis mikro

Pada tanggal 12 september 2017, FDA menerbitkan draft pedoman mengenai rekomendasi pelaksanaan uji non klinis untuk obat diagnostic radiofarmaka dosis mikro. Di dalam pedoman ini terdapat diskusi mengenai bagaimana pelaksanaan studi non klinis untuk obat-obatan khusus yang memiliki kharakteristik tersendiri, misalnya pemberian dosis mikro, obat berlabel radiofarmaka, penggunaan…

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PEMBUATAN SECARA ASEPTIK

PIC/S ANEKS 1 (PEMBUATAN PRODUK STERIL) – PEMBUATAN SECARA ASEPTIK NO VERSI ASLI VERSI TERJEMAHAN 31 Components after washing should be handled in at least a grade D environment. Handling of sterile starting materials and components, unless subjected to sterilisation or filtration through a micro-organism-retaining filter…

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – DOKUMENTASI

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – DOKUMENTASI NO VERSI ASLI VERSI TERJEMAHAN 26 Specifications for biological starting materials may need additional documentation on the source, origin, distribution chain, method of manufacture, and controls applied, to assure…

PIC/S ANEKS 3 (PEMBUATAN RADIOFARMAKA) – PRINSIP

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…

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B3. PRODUK IMONUSERA HEWAN

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B3. PRODUK IMUNOSERA HEWAN NO VERSI ASLI VERSI TERJEMAHAN 1 Particular care should be exercised on the control of antigens of biological origin to assure their quality, consistency and freedom…

PIC/S BAB II (PERSONALIA) – PRINSIP UMUM

BAB II (PERSONALIA) – PRINSIP NO VERSI ASLI VERSI TERJEMAHAN The correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual…

PIC/S BAB II (PERSONALIA) – PELATIHAN

BAB II (PERSONALIA) – PELATIHAN NO VERSI ASLI VERSI TERJEMAHAN 2.10 The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for…