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PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENDUKUNG

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENDUKUNG NO VERSI ASLI VERSI TERJEMAHAN 3.30 Rest and refreshment rooms should be separate from other areas. Ruang istirahat dan ruang makan minum harus terpisah dari daerah lain. INTERPRETASI…

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENGAWASAN MUTU

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENGAWASAN MUTU NO VERSI ASLI VERSI TERJEMAHAN 3.26 Normally, Quality Control laboratories should be separated from production areas. This is particularly important for laboratories for the control of biologicals, microbiologicals and radioisotopes, which should also be separated from…

Mengenal Istilah 21CFR Part 11 – Electronic Record & Electronic Signature

Knowing 21 CFR Part 11 Terms (Mengenal istilah 21 CFR Part 11) Apa itu 21CFR11 atau FDA 21 CFR Part 11? FDA (Food and Drug Administration) adalah sebuah bagian dari Departemen Pelayanan Kesehatan dan Publik yang menangani kesehatan publik masyarakat…

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENYIMPANAN

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PENYIMPANAN NO VERSI ASLI VERSI TERJEMAHAN 3.18 Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished…

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PRODUKSI

PIC/S BAB III (FASILITAS DAN PERALATAN) – AREA PRODUKSI NO VERSI ASLI VERSI TERJEMAHAN 3.6 In order to minimise the risk of a serious medical hazard due to cross-contamination, dedicated and self-contained facilities must be available for the production of particular medicinal products, such as highly…

Apa Perbedaan antara GMP Eropa (EU GMP) dan GMP Amerika (FDA GMP)?

Kedua pedoman ini sebenarnya memiliki banyak kesamaan, namun demikian terdapat beberapa perbedaan. Misalnya: Pengkajian Produk Tahunan atau Pengkajian Mutu Produk Tujuan dari “Annual Product Review” (APR) atau Pengkajian Produk Tahunan menurut FDA adalah untuk mengkaji standar mutu setiap produk dan menentukan adanya kebutuhan terhadap perubahan spesifikasi…

PIC/S BAB III (FASILITAS DAN PERALATAN) – PRINSIP & UMUM

BAB III (FASILITAS DAN PERALATAN) – PRINSIP & UMUM PRINSIP NO VERSI ASLI VERSI TERJEMAHAN Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout…

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 BAB II (PERSONALIA) – HIGIENE PERORANGAN

BAB II (PERSONALIA) – HIGIENE PERORANGAN NO VERSI ASLI VERSI TERJEMAHAN 2.15 Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These…

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…