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"Praktek kerja profesi di PT. Fonko International Pharmaceuticals dilaksanakan pada tanggal 11 Juli ndash; 9 September 2016. Pelaksanaan praktek kerja profesi ini memiliki tujuan umum agar calon apoteker mengerti peranan, tugas dan tanggung jawab apoteker di industri Farmasi; memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi; memahami penerapan CPOB di Industri Farmasi; serta memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi.

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Internship at PT. Fonko International Pharmaceuticals was done at 11 July ndash 9 September 2016. This internship has main purpose so that the student understand the roles, tasks, and the responsibilities of Pharmacist in Pharmaceutical Company the students have concepts, knowledges, skills, and experiences to do pharmaceutical practices in Pharmaceutical Company the students can apply GMP in Pharmaceutical Company and also the students have real picture about pharmaceutical practice problems in Pharmaceutical Companies."

"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."

"Praktek Kerja Profesi Apoteker di PT Fonko International Pharmaceuticals bertujuan untuk calon apoteker mampu memahami tugas dan tanggung jawab apoteker dalam industri farmasi, memahami peranan GMP di industri Farmasi dan memberikan gambaran nyata tentang permasalahan pekerjaan kefarmasiaan di Industri Farmasi. Tugas khusus yang diberikan berjudul Membuat Protokol Kualifikasi Instalasi dan Operasional alat Fride-freezer Liebher . Tujuan dari tugas khusus ini adalah untuk mengetahui alur pembuatan protokol kualifikasi di industry farmasi.

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Profession Internship at PT Fonko International Pharmaceuticals aiming for that prospective pharmacists are able to understand the duties and responsibilities of pharmacists in the pharmaceutical industry, understanding role of GMP in Industry, and have a real picture of the issues pharmaceutical practice and learn the strategies and activities that can be done in the framework of the development of pharmacy practice. Given the special task entitled Making Instalasi and Operational Qualfication Protocol tools Fridge-Freezer Liebher. The purpose of this special task is to knowing role of making qualification protocol in pharmaceutical industry.

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"ABSTRAKPraktek kerja profesi di PT. Taisho Pharmaceutical Indonesia, Tbk. dilaksanakan selama dua bulan dimulai dari bulan Juli 2016 hingga September 2016. Tujuan dilaksanakannya praktek kerja profesi ini adalah agar calon Apoteker mampu memahami peranan, tugas dan tanggung jawab apoteker dalam pelaksanaan pekerjaan kefarmasian di industri farmasi meliputi penerapan Cara Pembuatan Obat yang Baik CPOB . PT. Taisho Pharmaceutical Indonesia, Tbk. telah menerapkan CPOB sesuai dengan Peraturan Kepala Badan POM yang berlaku. Penerapan CPOB yang dilakukan meliputi 12 aspek yaitu, Manajemen Mutu, Personalia, Bangunan dan Fasilitas, Peralatan, Sanitasi dan Higiene, Pengawasan Mutu, Produksi, Inspeksi Diri dan Audit Mutu, Penanganan Keluhan Terhadap Produk, Dokumentasi, Pembuatan Analisis Berdasarkan Kontrak, Kualifikasi dan Validasi. Apoteker sebagai personil kunci harus memiliki kompetensi pada bidang pemastian mutu, pengawasan mutu, dan produksi.

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ABSTRACTInternship in PT. Taisho Pharmaceutical Indonesia, Tbk. was held for two months, from July 2016 until September 2016. The objective of the working practice of this profession is to make pharmacists understand the role, duties and responsibilities in the implementation of pharmacy jobs in the pharmaceutical industry include the application of Good Manufacturing Practice GMP . PT. Taisho Pharmaceutical Indonesia, Tbk. has implemented GMP in accordance with Regulation of the BPOM applicable. The implementation of GMP was conducted on the 12 aspects, namely, Quality Management, Personnel, Building and Facilities, Equipment, Sanitation and Hygiene, Quality Control, Production, Inspection and Self Quality Audits, Complaint Handling the Product, Documentation, Preparation Analysis Based Contracts, Qualification and Validation , Pharmacists as key personnel must have competence in the field of quality assurance, quality control, and production."

"ABSTRAKPraktek Kerja Profesi Apoteker PKPA merupakan kegiatan bagi mahasiswa apoteker untuk mempelajari secara langsung pekerjaan kefarmasian. PKPA di PT Actavis Indonesia bertujuan agar mahasiswa apoteker mengerti peran, tugas, dan tanggung jawab apoteker di industri farmasi; memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri; memahami penerapan CPOB di industri farmasi; dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. PKPA dilakukan selama 8 delapan minggu. Pada PKPA, mahasiswa melakukan pengamatan secara umum dan pengamatan secara langsung. Pengamatan secara umum dilakukan dengan menerima materi presentasi dari PT Actavis Indonesia, sedangkan pengamatan secara langsung dilakukan dengan mengunjungi suatu fasilitas di departemen terkait. Terdapat tugas khusus yang bertujuan untuk mengamati dan menganalisis permasalahan dari proses produksi Floxapen Dry Syrup; kemudian merekomendasikan tindakan perbaikan atau peningkatan pada proses produksi Floxapen Dry Syrup.

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ABSTRACTPharmacist Internship PKPA is an activity for pharmacist students to learn directly pharmaceutical job. PKPA in PT Actavis Indonesia aims to make students understand the role of the pharmacist, duties, and responsibilities of pharmacists in the pharmaceutical industry have the insight, knowledge, skills, and practical experience to do the job in the pharmaceutical industry understanding the application of GMP in the pharmaceutical industry and have a real picture of the problems of pharmaceutical job in the pharmaceutical industry. PKPA performed for 8 eight weeks. In PKPA, student performs general observation and direct observation. General observation is done by receiving teaching materials from PT Actavis Indonesia, whereas direct observations done by visiting a facility in relevant departments. There is a special task that aims to observe and analyze the problems of the production process of Floxapen Dry Syrup then recommend the corrective action or improvement in the production process of Floxapen Dry Syrup."

"ABSTRAKPraktek Kerja Profesi Apoteker di PT. Taisho Pharmaceutical Indonesia, Tbk. bertujuan untuk memahami dan mengerti peranan, tugas dan tanggungjawab apoteker di Industri Farmasi. Praktek kerja ini juga bertujuan agar mahasiswa memiliki wawasan, pengetahuan, keterampilan dan pengalaman praktis dalam melakukan pekerjaan kefarmasian, serta memahami penerapan Cara Pembuatan Obat yang Baik di Industri Farmasi. Tugas khusus yang diberikan berjudul Revisi Standar Operasional Prosedur SOP di Ruang Produksi Kelas E dan F PT. Taisho Pharmaceutical Indonesia, Tbk. Tujuan penyusunan tugas khusus ini adalah untuk menghasilkan SOP mengenai cara set up, pengoperasian, pembersihan alat/mesin di area produksi yang lebih jelas, singkat, padat, sederhana dan mudah dipahami sehingga dapat meminimalkan kesalahan prosedur.

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ABSTRACTInternship at PT. Taisho Pharmaceutical Indonesia, Tbk. was intended to make apothecary student understand roles and responsibilities of pharmacist in Pharmacy Industry. This internship also have an objective to make apothecary student have concept, knowledge, skill and practical experience in conducting pharmaceutical jobs, also understand implementation of Good Manufacturing Practice GMP in Pharmacy Industry. The internship given a special assignment titled Revision of Standard Operating Procedure SOP in Class E and F at PT. Taisho Pharmaceutical Indonesia, Tbk. The aim of this special assignment are to produce Standard Operating Procedure SOP about set up operating cleaning process of instrument machine in production area more clearly, briefly and easy to understand, so it can minimize procedural errors. "

"ABSTRAKPraktek kerja profesi di Industri PT. Guardian Pharmatama yang dilaksanakan bulan Juli - September tahun 2016 bertujuan untuk mengerti peranan, tugas, dan tanggung jawab apoteker di Industri Farmasi; memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi; memahami penerapan GMP CPOB di Industri Farmasi; dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Praktek kerja profesi ini juga ditunjang dengan tugas khusus yaitu pembuatan form rekonsiliasi produk, material kemas, dan bendera untuk departemen produksi di PT. Guardian Pharmatama. Tujuan dari tugas khusus ini adalah untuk mengetahui tata cara perhitungan rekonsiliasi, mengetahui cara pembuatan prosedur tetap di PT. Guardian Pharmatama, mempermudah manajemen PT. Guardian Pharmatama dalam melakukan investigasi produk, dan mencegah complain dari pelanggan terkait lolosnya sambungan foil pada strip atau blister.

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ABSTRACTInternship at PT. Guardian Pharmatama, was held on July September 2016, aims to understand the role, duties, and responsibilities of pharmacists at pharmaceutical industry to have knowledges, skills, and experience to do the pharmaceutical works at pharmaceutical industry to understand the application GMP CPOB at pharmaceutical industry and to have knowledge about the problem about pharmaceutical works at pharmaceutical industry. The internship also gives the author experience to do a special task about making a product reconciliation, packaging material reconciliation, and flags for production department at PT. Guardian Pharmatama. The special task aims to determine the procedure for calculation of reconciliation, knowing how to make Standard Operational Procedure SOP at PT. Guardian Phamatama, helping the managerial of PT. Guardian Pharmatama for product investigation, and prevention of complaining from consumer because the pass of foil connection at strip or blister."

"ABSTRAKPraktek Kerja Profesi PKP di PT. Actavis Indonesia dilakukan pada tanggal 18 July ndash; 9 Septembet 2016. Tujuan pelaksanaan PKP untuk memperoleh gambaran dan pengalaman mengenai peran profesi apoteker di industri farmasi, khususnya dalam bidang pemastian mutu. 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 . Kegiatan yang dilakukan selama PKP antara lain pengenalan secara umum mengenai PT. Actavis Indonesia; induksi ke departemen yang berkaitan dengan pekerjaan kefarmasian yaitu gudang, AMD Pharmtech, Production Planning Inventory Control PPIC , Produksi Multi Product Facility MPF , Quality Control QC , Quality Assurance QA , Scientific Affairs SCA , serta Engineering dan EHS. Actavis Indonesia 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.

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ABSTRACTProfession internship at PT. Actavis Indonesia held on July 18th to September 9th 2016. The aim of profession internship to obtain an overview and experience of professional role of pharmacists in pharmaceutical industry, particularly in a quality assurance. 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 . Activities conducted during profession internship among other general introduction about PT. Actavis Indonesia induction into department which related pharmacy that are Warehouse, AMD Pharmtech, Production Planning Inventory Control PPIC , Production of Multi Product Facility MPF , Quality Control QC , Quality Assurance QA , Scientific Affairs SCA , and Engineering and EHS. Actavis Indonesia 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."

"ABSTRAKIndustri farmasi merupakan salah satu sarana tempat dilakukan pekerjaan kefarmasian. Praktik kerja profesi yang dilaksanakan di PT Medifarma Laboratories ini, bertujuan agar mahasiswa mendapatkan pengalaman nyata dalam melakukan pekerjaan kefarmasian di industri farmasi. Industri farmasi adalah badan usaha yang memiliki izin untuk melakukan kegiatan pembuatan obat atau bahan obat. Dalam pembuatan obat, industri farmasi harus memenuhi ketentuan Cara Pembuatan Obat yang Baik CPOB agar obat yang dihasilkan aman, berkhasiat dan bermutu. Seluruh aspek CPOB telah diterapkan oleh PT Medifarma Laboratories. Selain itu, PT Medifarma Laboratories juga menerapkan ketentuan GMP dari PIC/s sebagai jaminan tambahan untk keperluan ekspor produk. Seluruh proses produksi dan aspek terkait telah dikendalikan, dan setiap tahapnya telah terdokumentasikan. Salah satu upaya pengendalian dalam proses produksi adalah validasi proses yang menjadi tugas khusus yang diberikan kepada mahasiswa. Validasi proses merupakan usaha untuk membangun bukti terdokumentasi bahwa suatu proses produksi akan senantiasa menghasilkan produk yang memenuhi kriteria yang ditentukan. Validasi ini termasuk dalam validasi konkuren, dilakukan terhadap pada tiga bets tablet suplemen XYZ berturut-turut, dimana tiap bets berukuran 100.000 tablet. Validasi proses telah dilakukan mulai dari tahap wet compounding, dry mixing, compression dan coating. Validasi terhadap proses blistering tablet suplemen XYZ juga telah dilakukan. Dari hasil validasi, disimpulkan bahwa proses produksi tiga bets tablet suplemen XYZ telah tervalidasi.

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ABSTRACTThe pharmaceutical industry is one of the places to do the pharmaceutical works. The internship that held at PT Medifarma Laboratories, intended to make students get the real experience in performing the pharmaceutical works in the pharmaceutical industry. The pharmaceutical industry is an entity that has a license to conduct the manufacture of drugs or drug ingredients. In the manufacture of drugs, the pharmaceutical industry must comply Good Manufacturing Practice GMP so that the resulting drug meet the criteria of safe, efficacy and quality. All aspects of GMP has been applied by PT Medifarma Laboratories. In addition, PT Medifarma Laboratories also applying the GMP provisions of PIC s as an additional guarantee for export products. The whole process of production and its related aspects are controlled, and every stage is documented. One of the actions in order to control the production process is validation process that became task given to the student. The validation process is establishing documented evidence to determine that process consistently produce a product meet its predetermined specifications and quality characteristics. Validation that had been done is classified as concurrent validation, and were carried out on three batches of Tablet Supplements XYZ, where the size of each batch were 100.000 tablets. Validation process were started from wet compounding, dry mixing, compression, and coating. Validation of the blistering process Tablets Supplement XYZ had also been performed. The results showed that the production process of three batches of Tablet Supplements XYZ had been validated."