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"Dalam Peraturan Kepala BPOM No. HK 03.1.23.10.11.08481 tahun 2011 menyebutkan bahwa sediaan farmasi termasuk obat yang beredar harus memenuhi persyaratan khasiat, keamanan dan mutu yang harus dipenuhi oleh industri farmasi. Pedoman bagi suatu industri farmasi dalam proses produksi dan segala aspek yang terkait di dalamnya diatur dalam Cara Pembuatan Obat yang Baik (CPOB). Hal ini merupakan salah satu tanggung jawab apoteker karena sesuai dengan PP RI No. 51 tahun 2009, salah satu fasilitas kefarmasian tempat pengabdian apoteker adalah fasilitas produksi sediaan farmasi atau Industri farmasi. Praktek Kerja Profesi dilakukan pada bulan April-Mei 2016 di PT Actavis Indonesia. Praktek kerja profesi ini bertujuan untuk memahami tugas dan tanggung jawab apoteker di PT Actavis Indonesia dan untuk memahami penerapan Cara Pembuatan Obat yang Baik (CPOB) di Industri Farmasi.

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According regulation from Chief of BPOM No. HK 03.1.23.10.11.08481 pharmaceutical preparations including drug should meet the requirements of efficacy, safety and quality that must be met by the pharmaceutical industry. Guidelines for a pharmaceutical industry in the production process and all aspects related to it set in Good Manufacturing Practice (GMP). This is one of responsibility of a pharmacist because base on PP 51 ON 2009 one of the pharmaceutical facility where pharmacists should dedicated their pharmaceutical services is the pharmaceutical industry. Internship was held in April-May 2016 at PT Actavis Indonesia. This Internship was aimed to understand the roles and responsibilities of pharmacists in PT Actavis Indonesia and to understand the application of Good Manufacturing Practice (GMP) in the Pharmaceutical Industry."

"ABSTRAKPraktek Kerja Profesi (PKP) di industri farmasi dilaksanakan di DepartemenQuality Control (QC) PT Medifarma Laboratories. Kegiatan ini berlangsungselama 2 bulan dari tanggal 1 Juli sampai dengan tanggal 31 Agustus 2015. PKP diindustri bertujuan agar mahasiswa apoteker mengerti peranan, tugas, dan tanggungjawab Apoteker di Industri Farmasi; memiliki wawasan, pengetahuan,keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian diIndustri Farmasi; memahami penerapan CPOB di Industri Farmasi; memilikigambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi.Berdasarkan kegiatan PKP yang dilakukan, dapat disimpulkan bahwa peranapoteker penting untuk menghasilkan obat-obatan yang aman, bermutu, danberkhasiat. Apoteker di Departemen QC bertanggung jawab untuk melakukanpengawasan mutu terhadap produk yang diproduski dan memastikan bahwapengujian yang diperlukan dan relevan telah dilakukan dan bahwa bahan yangbelum diluluskan tidak digunakan serta produk yang belum diluluskan tidak dijualatau dipasok sebelum mutunya dinilai dan dinyatakan memenuhi syarat. Mahasiswaapoteker telah berhasil memperoleh gambaran umum dari pelaksanaan pekerjaankefarmasian di PT Medifarma., khususnya di bidang QC yaitu melakukan analisisterhadap bahan awal, produk jadi, inspeksi bahan awal. Dalam melakukan tugasnyadi QC juga mahasiswa apoteker membuat Spreadsheet dan cara memvalidasinyauntuk mendukung analisis dan inspeksi bahan awal. Adanya PKP di PT MedifarmaLaboratories yang telah melaksanakan CPOB dengan baik di semua aspek, pesertaPKP lebih banyak mengetahui dan memahami seperti apa pelaksanaan CPOBsecara real dalam sebuah Industri. Seperti Industri yang lainnya PT MedifarmaLaboratories juga memiliki masalah seperti berpikir bagaimana mengatasi wastetime pada proses maupun para pekerja sehingga suatu proses berlangsung lebihcepat tetapi tetap menghasilkan hasil yang baik dan dapat dipertanggungjawabkan,Oleh karena itu, Apoteker harus memiliki wawasan, pengetahuan dan kreatifitassehingga dapat mengatasi masalah-masalah tersebut.

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ABSTRACTProfession Internship at pharmaceutical industry was held at Quality Control (QC)Department of PT Medifarma Laboratories. This activity was held for two monthfrom July 1st until August 31th 2015. Profession internship at pharmaceuticalindustry was intended to make apothecary student understand the role ofpharmacist, have insight into the implementation of pharmaceutical practice,understand the implementation of Cara Pembuatan Obat yang Baik (CPOB), andknow the issues in pharmaceutical practice in pharmaceutical industry. Based onthe activities, Apothecary at QC Department is responsible for supervising thequality of the product diproduski and ensure that the necessary and relevant testshave been conducted and that the materials have not been approved are not used aswell as products that have not been approved are not sold or supplied before thequality was assessed and found eligible. Apothecary student have obtained insightinto general routine activities in QC Department, those were an analysis of thestarting materials, finished products, inspection of the starting material. Inperforming the task in QC department, apothecary student make a spreadsheet andvalidate them to support the analysis and inspection of the starting material. PTMedifarma Laboratories that has implemented the GMP well in all aspects, giveapothecary student more aware and understand what the real implementation ofGMP in an industry. Such as Industrial others, PT Medifarma Laboratories also hasa problem such as find solution how to solve waste time in the process or theworkers, so that a process was faster but still produce good results. Therefore,pharmacists should have the insight, knowledge and creativity so that can overcomethe problems.;Profession Internship at pharmaceutical industry was held at Quality Control (QC)Department of PT Medifarma Laboratories. This activity was held for two monthfrom July 1st until August 31th 2015. Profession internship at pharmaceuticalindustry was intended to make apothecary student understand the role ofpharmacist, have insight into the implementation of pharmaceutical practice,understand the implementation of Cara Pembuatan Obat yang Baik (CPOB), andknow the issues in pharmaceutical practice in pharmaceutical industry. Based onthe activities, Apothecary at QC Department is responsible for supervising thequality of the product diproduski and ensure that the necessary and relevant testshave been conducted and that the materials have not been approved are not used aswell as products that have not been approved are not sold or supplied before thequality was assessed and found eligible. Apothecary student have obtained insightinto general routine activities in QC Department, those were an analysis of thestarting materials, finished products, inspection of the starting material. Inperforming the task in QC department, apothecary student make a spreadsheet andvalidate them to support the analysis and inspection of the starting material. PTMedifarma Laboratories that has implemented the GMP well in all aspects, giveapothecary student more aware and understand what the real implementation ofGMP in an industry. Such as Industrial others, PT Medifarma Laboratories also hasa problem such as find solution how to solve waste time in the process or theworkers, so that a process was faster but still produce good results. Therefore,pharmacists should have the insight, knowledge and creativity so that can overcomethe problems."

"Praktek Kerja Profesi dilaksanakan di PT. Bintang Toedjoe Plant Pulogadung bertujuan agar mahasiswa dapat mengetahui dan memahami peranan, tugas, dan tanggung jawab apoteker di dalam sebuah industri farmasi; mengetahui dan memahami pelaksanaan penerapan CPOB di PT. Bintang Toedjoe; memiliki wawasan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan farmasi industri serta gambaran nyata tentang permasalahan dan cara pengatasinya. Tugas khusus yang diberikan berjudul Diversifikasi Bahan Baku Ananas comosus Extract pada ?Promag Gazero? dan Parasetamol pada "Laila". Tugas khusus ini bertujuan untuk mengetahui hasil formulasi sediaan cair "Promag Gazero" dan sediaan serbuk "Laila", serta untuk membandingkan hasil uji fisik dan kimia "Promag Gazero" dan "Laila" hasil diversifikasi dengan produk existing. Analisis fisika dan kimia sediaan "Promag Gazero" dengan modifikasi bahan baku Ananas comosus extract dan sediaan serbuk "Laila" dengan modifikasi bahan baku parasetamol menghasilkan produk yang berada dalam rentang spesifikasi yang ditentukan.

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Professional Internship was held at PT. Bintang Toedjoe on Pulogadung Plant, intended to allow student to comprehending and understanding the role, duties and responsibilities of a pharmacist in the pharmaceutical industry; to comprehending and understanding the implementation of GMP in PT. Bintang Toedjoe; having knowledge, skills, and practical experience to do the job in the pharmaceutical industry and knowing of the problems faced, also solutions to solve these problems. Special assignment given titled Ananas comosus Extract Diversification on ?Promag Gazero? and Paracetamol on "Laila". The purpose of special assigment are to understand formulation result liquid dosage form "Promag Gazero" and powder dosage form "Laila", and to compare the physical and chemical test results of "Promag Gazero" and "Laila" product diversification with existing product. Physic and chemical analysis of "Promag Gazero" with Ananas comosus extract modified and powder "Laila" with paracetamol modified showed product in a given spesification."

"ABSTRAKPraktek Kerja Profesi Apoteker di PT Actavis Indonesia bertujuan agar calon apoteker mengerti peranan, tugas dan tanggung jawab apoteker di Industri Farmasi dan memahami penerapan CPOB di Industri Farmasi. Sebagaimana yang diketahui bahwa tenaga kesehatan dalam industri farmasi yang turut berperan dalam menghasilkan obat yang bermutu, aman, dan berkhasiat adalah apoteker. Kedudukan apoteker juga diatur dalam peraturan perundang-undangan, yaitu sebagai penanggung jawab produksi, pengawasan mutu dan pemastian mutu. Selain sebagai personil kunci, apoteker juga dibutuhkan di bidang-bidang lain yang memerlukan keahlian dan pengetahuan dalam bidang kefarmasian seperti PPIC, pengembangan produk dan regulasi. Selain itu, tugas khusus yang diberikan adalah mengenai pembuatan user requirement spesification, yang mana merupakan dokumen berisi spesifikasi dari peralatan yang akan diadakan

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ABSTRACTInternship at PT Actavis Indonesia aims to understand the role, duties, and responsibilities of the prospective apothecary in pharmaceutical industry. In addition, the aim is to understand the application of GMP in Pharmaceutical Industry, though. Health profession in the pharmaceutical industry, also plays a role in producing the drug quality, safe, and nutritious food, is an apothecary. The role of apothecary as a key personel, which is as the responsible production, quality control and quality assurance. Not only plays as key personel, apithecary is also needed in other fields that require expertise and knowledge in the field of pharmaceuticals as PPIC, product development and regulation. Furthermore, given the specific task is about making the user requirement specification, which is a document about the specifications of the equipment will be held."