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"ABSTRAKPraktek Kerja Profesi di PT. AstraZeneca Indonesia Cikarang-Site Periode Maret-April 2017 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, serta memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi.Selama melakukan praktik kerja, mahasiswa bertugas di bidang Pengawasan Mutu dan melakukan berbagai kegiatan yang termasuk dalam tugas pokok pengawasan mutu di industri farmasi, yaitu kualifikasi alat-alat di laboratorium, audit laboratorium, pemantauan lingkungan, dan mengkaji hasil uji di luar spesifikasi. Praktik kerja profesi dilakukan selama dua bulan dengan tugas khusus yaitu Proses Kualifikasi Alat Purified Water di PT. AstraZeneca Indonesia.

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ABSTRACTInternship at PT. AstraZeneca Indonesia Cikarang Site was intended to have insight, knowledge, and practical experience in doing pharmaceutical practice in pharmaceutical industry, have knowledge and understanding about standard of pharmaceutical practice performed in PT. AstraZeneca Indonesia, have description about roles, functions, and responsibilities as an apothecary in pharmaceutical industry, and understand to solve problems happened during working in pharmaceutical industry. During practice, student was performed several activity related to pharmaceutical industry practice, such as lab equipments qualification, laboratory audit, environmental monitoring, and out of specification review. Internship was performed for two months with specific assignment titled Qualification Process of Water Purifier in PT. AstraZeneca Indonesia."

"ABSTRAKIndustri farmasi memiliki peranan penting dalam pelayanan kesehatan terkait dengan produk obat yang dihasilkannya. Industri farmasi berkewajiban menjamin bahwa obat yang dihasilkan harus memiliki khasiat, keamanan dan kualitas yang memenuhi standar yang telah ditetapkan yaitu Cara Pembuatan Obat yang Baik CPOB . Pemerintah dan industri farmasi bertanggung jawab dalam proses pembuatan obat dengan penerapan CPOB yang dilakukan secara konsisten agar obat yang di hasilkan memiliki kualitas yang baik dan melindungi konsumen. Pelaksanaan Praktek Kerja Profesi Apoteker PKPA di PT. AstraZeneca Indonesia merupakan salah satu sarana bagi calon Apoteker mendapatkan ilmu serta pengetahuan secara mendalam tentang penerapan CPOB pada industri farmasi. Calon apoteker diharapkan dapat mengerti peranan, tugas dan tanggung jawab Apoteker di Industri Farmasi. Selain itu, calon apoteker diharapkan memiliki pengetahuan dan pengalaman praktis serta memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Calon Apoteker juga diberikan tugas khusus yang berjudul ldquo;Commissioning Testing Alat Thermohygrometer untuk Area Cool Warehouse rdquo;. Tugas khusus ini bertujuan agar calon apoteker dapat mempelajari proses penyiapan dan penyusunan dokumen serta melakukan pengujian commissioning alat Thermohygrometer sebagai rangkaian proses kualifikasi alat di PT. AstraZeneca Indonesia.

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ABSTRACTThe pharmaceutical industry has an important role in the health services related with the resulting drug products. The pharmaceutical industry is obliged to guarantee the resulting drug product must have efficacy, safety and quality according to the established standard i.e. Good Manufacturing Product GMP . The government and the pharmaceutical industry are responsible in the drug production process with the application of GMP must be consistently implement in order to produced the drug with good quality and protect the customers. Internship program at PT. AstraZeneca Indonesia was one of the tools for students to gain deep knowledge about the application of GMP in pharmaceutical industry. The students are expected to understand about the role, duties and responsibilities of pharmacist in the pharmaceutical industry. Other than that, the students are ecpected to have practical knowledge and experience with a clear picture of the pharmaceutical work problems in the pharmaceutical industry. Student was also given a special assignment entitled ldquo Commissioning Testing of Thermohygrometer for Cool Warehouse Area rdquo . This special assignment was aim to student to study about the process of preparing up to compiling the document and performing the commissioning protocol of Thermohygrometer as a series of qualification process at PT. AstraZeneca Indonesia."

"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. AstraZeneca Indonesia-Cikarang Site dilakukan pada tanggal 4 Januari hingga 28 February 2017. Tujuan pelaksanaan PKP untuk memperoleh gambaran dan pengalaman mengenai peran profesi apoteker di industri farmasi, khususnya dalam bidang produksi. Kegiatan yang dilakukan selama PKP antara lain pengenalan secara umum mengenai PT. AstraZeneca Indonesia, induksi ke departemen yang berkaitan dengan pekerjaan kefarmasian, dan membantu pekerjaan di Departemen Produksi seperti melakukan optimasi proses produksi tablet inderal dan optimasi proses wet cleaning pada mesin dan peralatan produksi ruang primary packaging. PT. AstraZeneca 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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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 AstraZeneca Indonesia Cikarang Site Ltd. held on January 4st to February 28th 2017. The aim of profession internship to obtain an overview and experience of professional role of pharmacists in pharmaceutical industry, particularly in a production. Activities conducted during profession internship among other general introduction about AstraZeneca Indonesia Ciakarang Site Ltd, induction into department which related pharmacy, and help the task at Production Department for optimization of inderal tablet production process and optimization of wet cleaning process on machine and equipment in primary packaging room. AstraZeneca Indonesi Cikarang Site Ltd. 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."

"Laporan praktik kerja ini membahas tentang praktik kerja yang dilakukan mahasiswa di PT AstraZeneca Indonesia-Cikarang Site bertujuan untuk mengerti peranan, tugas dan tanggung-jawab apoteker serta memiliki wawasan, pengetahuan, keterampilan dan pengalaman praktis untuk melakukan pekerjaan kefarmasiaan di Industri Farmasi. Selain itu untuk memahami penerapan GMP CPOB dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Tugas Khusus yang diberikan yaitu ldquo;Pembuatan Dokumen Kualifikasi untuk Inkubator Panas dan Inkubator Dingin untuk Uji Mikrobiologi rdquo;. Penulisan laporan praktik kerja berdasarkan pengamatan langsung pada di Industri Farmasi. Hasil dari praktik kerja ini bahwa PT AstraZeneca Indonesia-Cikarang Site telah menerapkan semua aspek dalam CPOB, sehingga mahasiswa telah mengerti gambaran nyata penerapan CPOB serta memahami tugas dan tanggung-jawab apoteker di Industri Farmasi.

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The focus of this study is the work practices undertaken by students at PT AstraZeneca Indonesia-Cikarang Site aims to understand the role, duties, and responsibilities of pharmacists and have the insight, knowledge, skills and practical experience to undertake pharmaceutical work in the Pharmaceutical Industry. In addition to understanding the implementation of GMP CPOB and has a real picture of the pharmaceutical work problems in the Pharmaceutical Industry. The special assignment is Making Qualification Documents for Hot Incubators and Cold Incubators for Microbiological Testing . Practical report writing based on direct observation on the Pharmaceutical Industry. The result of this working practice is that PT AstraZeneca Indonesia-Cikarang Site has applied all aspects of CPOB, so that the students have understood the real picture of CPOB application and understand the duty and responsibility of the pharmacist in the Pharmaceutical Industry."

"Praktik kerja profesi di PT AstraZeneca Cikarang-Indonesia Periode Bulan Januari ndash; Februari Tahun 2018 bertujuan untuk memahami peran, tugas, serta tanggung jawab Apoteker di Industri Farmasi dan memahami penerapan GMP/CPOB di Industri Farmasi, selain itu untuk memiliki wawasan, pengetahuan, keterampilan dan pengalaman guna melakukan pekerjaan kefarmasian di Industri Farmasi, serta memiliki pemahaman terkait permasalahan pekerjaan kefarmasian di Industri Farmasi. Tugas khusus yang diberikan yaitu berjudul ldquo;Penentuan Waktu Pelaksanaan Peninjauan Berkala Dokumen Kualifikasi Alat di PT AstraZeneca Cikarang-Indonesia rdquo;. Tujuan dari pelaksanaan tugas khusus di PT AstraZeneca Cikarang-Indonesia adalah untuk menentukan waktu pelaksanaan peninjauan berkala periodic review terhadap seluruh dokumen kualifikasi alat dan/atau sistem yang digunakan oleh PT AstraZeneca Cikarang-Indonesia berdasarkan analisis risiko. Secara umum, PT AstraZeneca Cikarang-Indonesia telah menerapkan 12 aspek CPOB dengan baik dan benar, penulis juga telah mendapatkan kemampuan untuk memahami peran, tugas, wawasan dan tanggung jawab apoteker dan memberikan solusi pada permasalahan di industri farmasi.

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Internship at PT AstraZeneca Cikarang Site-Indonesia Period January - February 2018 aims to understand the roles, duties and responsibilities of pharmacists in the pharmaceutical industry, and also to understand the practice of good manufacturing practice GMP /CPOB in the pharmaceutical industry. In addition, the pharmacist candidate can also have the insight, knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry, as well as have an understanding of the problems related to pharmaceutical practice in the pharmaceutical industry. The special assignment given is ldquo;Determination of the implementation timing of the periodic review equipment qualification document in PT AstraZeneca Cikarang Site-Indonesia rdquo;. The purpose of this special assignment is to determine the implementation time of the periodic review of the entire qualification document equipments and/or systems used by PT AstraZeneca Cikarang Site-Indonesia based on risk analysis rdquo;. In general, PT AstraZeneca Cikarang Site-Indonesia has applied 12 aspects of GMP well and correctly, the authors also have the ability to understand the roles, duties, insights and responsibilities of pharmacists and provide solutions on products in the industry pharmacy "