ABSTRAK
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 CPOB . Praktek Kerja Profesi PKP di PT. Medifarma Laboratories dilakukan pada tanggal 1 Februari ndash; 31 Maret 2017. Tujuan pelaksanaan PKP untuk memperoleh gambaran dan pengalaman mengenai peran profesi apoteker di industri farmasi, khususnya dalam bidang pemastian mutu. Kegiatan yang dilakukan selama PKP antara lain pengenalan secara umum mengenai PT. Medifarma Laboratories; induksi ke departemen yang berkaitan dengan pekerjaan kefarmasian yaitu Quality Assurance QA , Quality Control QC , Engineering, Production, Health Safety Environment HSE , Manufacturing Technology Unit MTU , logistic, dan membantu pekerjaan di Departemen QA seperti memeriksa dokumen untuk pelolosan produk jadi, dan membuat dokumen registrasi salah satu produk Medifarma. Medifarma Laboratories merupakan salah satu industri farmasi yang telah menerapkan pedoman CPOB dalam setiap kegiatan yang dilakukan, baik dalam proses produksi, pengawasan dan pemastian mutu, serta kegiatan lain yang terkait.
ABSTRACT
Pharmaceutical industry is a corporation that has a license from Minister of Health to manufacturing of drugs or drug materials. Pharmaceutical industry is obliged to comply with the requirements of Good Manufacturing Practice for Pharmaceuticals GMP . Profession internship at PT. Medifarma Laboratories held on February 1st to March 31st 2017. The aim of profession internship to obtain an overview and experience of professional role of pharmacists in pharmaceutical industry, particularly in a quality assurance. Activities conducted during profession internship among other general introduction about PT. Medifarma Laboratories induction into department which related pharmacy that are Quality Assurance QA , Quality Control QC , Engineering, Production, Health Safety Environment HSE , Manufacturing Technology Unit MTU , logistic and help the task at QA Department such as review document for finish good release and making dossier for registration one of product in PT.Medifarma Laboratories. PT. Medifarma Laboratories is the one of pharmaceutical industry which has implemented the GMP guidelines in each of activities, both in production process, control and quality assurance, and other related activities. |
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