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"Praktek Kerja Profesi Apoteker di PT. Fonko International Pharmaceuticals bertujuan untuk memahami peran serta tanggung jawab Apoteker di industry farmasi, peran serta tanggung jawab transfer proses dan produk obat di Departemen Technical Service PT. Fonko International Pharmaceuticals, serta memahami proses pengembangan produk obat di industry farmasi sesuai dengan aturan pemerintah Indonesia. Tugas Khusus yang diberikan berjudul Pembuatan Dokumen Working Instruction Panduan Pelaksanaan Validasi Proses PT. Fonko International Pharmaceuticals. Tujuan penyusunan tugas khusus ini adalah memahami cara menyusun Working Instruction Panduan Pelaksanaan Validasi Proses dan memahamiaspek-aspek penting yang perlu diperhatikan dalam penyusunan Working Instruction Panduan Pelaksanaan Validasi Proses.

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Internship at PT. Fonko International Pharmaceuticals on July September 2016 has aims to understand the role and responsibilities of pharmacist in the pharmaceutical industry, roles and responsibilities for the product and process transfer of medicinal products in the Department of Technical Service, PT. Fonko International Pharmaceuticals, as well as understand the process of development of medicinal products in the pharmaceutical industry in accordance with the rules of the Indonesian government. Special task given entitled ldquo Creating Working Instruction Document of Process Validation Implementation Guide at PT. Fonko International Pharmaceuticals rdquo . The purpose of the main task is to understand how to create Working Instruction Document of Process Validation Implementation Guide and understand the important aspects that need to be considered to create Working Instruction Document of Process Validation Implementation Guide."

"Industri farmasi adalah badan usaha yang memiliki izin dari menteri kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat. Industri farmasi wajib memenuhi persyaratan Cara Pembuatan Obat yang Baik. Pembuatan obat yang benar mengandalkan sumber daya manusia. Dalam pengujian produk steril, kualifikasi personalia laboratorium merupakan aspek kritis yang berperan dalam memastikan validitas hasil. Oleh karena itu, Departemen Quality Control PT Fonko International Pharmaceuticals melaksanakan kualifikasi terhadap analis baru guna menetapkan kemampuan analis tersebut dalam melakukan analisis secara akurat. Kualifikasi analis dilakukan dengan membandingkan hasil analisis oleh analis yang dikualifikasi dengan hasil analis yang telah terkualifikasi sebelumnya sebanyak tiga replikasi. Berdasarkan hasilnya, para analis dinyatakan terkualifikasi dalam pengujian yang menggunakan autotitrator. Mereka juga dapat dinyatakan terkualifikasi dalam pengujian yang menggunakan high performance liquid chromatography (HPLC). Namun, para analis tetap harus mendapatkan Pelatihan Analisis Kimia Kuantitatif Kompleks untuk menilai pemahaman kedua analis terkait pengujian yang menggunakan HPLC.

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A pharmaceutical industry is a business entity who was given permission by the health ministry to produce drugs or raw drug materials. A pharmaceutical industry must adhere to the Good Manufacturing Practices. Good drug manufacturing relies on human resources. In the testing of sterile products, the qualifications of laboratory personnel is a critical aspect to ensure the validity of the results. Therefore, the Quality Control Department of PT Fonko International Pharmaceuticals performed qualifications on new analysts to establish their skills in doing accurate analysis. The qualification process was carried out by comparing the analysis results of the new analysts with a qualified analyst in three replicates. Based on the results, the new analysts are qualified to perform testing using the autotitrator. They can also be considered qualified in testing using the high performance liquid chromatography (HPLC), but they would still need to receive training on complex quantitative chemical analysis to assess their understanding on HPLC-related testing methods."