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"Industri farmasi memerlukan izin dari Kementerian Kesehatan untuk memproduksi obat dan mendapatkan Nomor Izin Edar untuk menjual produknya di pasar lokal atau internasional. Proses registrasi produk melibatkan pengajuan dossier, seperti Common Technical Document (CTD), yang berisi data administratif, ringkasan umum, klinis dan non-klinis, serta mutu obat. Dossier ini disesuaikan dengan persyaratan negara yang berbeda dan menggunakan format CTD yang diakui secara internasional. Untuk modul mutu, dokumen Risk Assessment Elemental Impurities diperlukan untuk mengendalikan kontaminan logam dalam produk jadi. Proses Risk Assessment ini penting untuk mengidentifikasi dan mengurangi risiko dari Elemental Impurities. Apoteker memainkan peran kunci dalam menyusun dokumen ini untuk memastikan keamanan produk farmasi. Usulan prosedur pembuatan Risk Assessment Elemental Impurities dalam Industri Farmasi disusun berdasarkan penelusuran literatur tatalaksana internasional yang berlaku. Proses pembuatan Risk Assessment dilakukan dengan tahapan: identifikasi Elemental Impurities, evaluasi tingkat Elemental Impurities dan membuat kesimpulan penilaian keamanan Elemental Impurities tersebut.......The pharmaceutical industry requires permission from the Ministry of Health to produce medicines and obtain a Marketing Permit Number to sell its products on local or international markets. The product registration process involves submitting documents, such as the Common Technical Document (CTD), which contains administrative data, general, clinical and non-clinical summaries, and drug quality. This dossier is adapted to the requirements of different countries and uses the internationally recognized CTD format. For the quality module, a Risk Assessment Elemental Impurities document is required to control metal contaminants in finished products. This Risk Assessment process is important to identify and reduce the risk of Elemental Impurities. Pharmacists play a key role in preparing these documents to ensure the safety of pharmaceutical products. The proposed procedure for creating a Risk Assessment for Elemental Impurities in the Pharmaceutical Industry was prepared based on a search of applicable international management literature. The process of making a Risk Assessment is carried out in stages: identifying Elemental Impurities, evaluating the level of Elemental Impurities and making conclusions regarding the security assessment of the Elemental Impurities."

"Genotoxic impurities adalah senyawa kimia yang membahayakan organisme dengan merusak materi genetik (DNA) yang dapat ditemukan dalam senyawa obat. Sebagai instansi pembuatan obat, industri farmasi memiliki izin dari menteri kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat, sehingga perlu mengetahui lebih dalam terkait Genotoxic impurities. Penelitian ini bertujuan untuk mengetahui definisi, jenis senyawa yang rentan, metode analisa dan perhitungan batas deteksi, serta upaya yang perlu dilakukan oleh PT. Novell Pharmaceutical Laboratories sebagai salah satu industri farmasi dalam menangani temuan genotoxic imutirities. Studi ini merupakan penelitian kualitatif dengan metode literature review untuk pelaksanaan penelitiannya. Pencarian database berupa Google Scholar, ResearchGate, Pubmed, acs.org. Hasil dari penilaian kualitas studi selanjutnya akan mengumpulkan dan menggali informasi berdasarkan analisa PICO (Problem, Purpose, Population, Intervention, Comparison, Outcome). Hasil penelitian menunjukkan jika genotoxic impurities bersifat karsinogenik dan dapat ditemukan dalam senyawa obatmelalui bahan awal dalam sintesis obat, zat antara dan produk sampingan yang terbentuk dalam proses sintesis, pelarut, katalis dan reagen yang digunakan dalam proses sintesis, serta produk degradasi yang dihasilkan pada penyimpanan dan pengiriman atau karena paparan cahaya, udara, oksidasi atau hidrolisis. Metode analisis yang dapat digunakan untuk mengidentifikasi keberadaan genotoxic impurities adalah dengan metode HPLC (High Performance Liquid Chromatography), GC (Gas Chromatography), TLC/HPTLC (Thin Layer Chromatography), dan elektroforesis kapiler dengan perhitungan batas deteksi menggunakan nilai TTC (threshold of toxicological concern) dan staged TTC....... Genotoxic impurities are chemical compounds that harm organisms by damaging genetic material (DNA) which can be found in drug compounds. As a drug manufacturing agency, the pharmaceutical industry has permission from the Minister of Health to carry out drug or medicinal ingredient manufacturing activities, so it is necessary to know more about Genotoxic impurities. This research aims to determine the definition, types of susceptible compounds, analysis methods and detection limit calculations, as well as the efforts that need to be made by PT. Novell Pharmaceutical Laboratories as one of the pharmaceutical industries in handling findings of genotoxic cuteirities. This study is qualitative research with a literature review method for conducting the research. Database searches include Google Scholar, ResearchGate, Pubmed, acs.org. The results of the study quality assessment will then collect and explore information based on PICO analysis (Problem, Purpose, Population, Intervention, Comparison, Outcome). The research results show that genotoxic impurities are carcinogenic and can be found in drug compounds through starting materials in drug synthesis, intermediates and by-products formed in the synthesis process, solvents, catalysts and reagents used in the synthesis process, as well as degradation products produced during storage. and shipping or due to exposure to light, air, oxidation or hydrolysis. Analytical methods that can be used to identify the presence of genotoxic impurities are HPLC (High Performance Liquid Chromatography), GC (Gas Chromatography), TLC/HPTLC (Thin Layer Chromatography), and capillary electrophoresis with detection limit calculations using the TTC (threshold of toxicological) value. concern) and staged TTC. Several efforts that can be made by active substance manufacturers to deal with genotoxic impurities are changes in synthesis, adjustment of reaction conditions to reduce the formation of genotoxic impurities, and purification of active substances."