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"ABSTRAKNama : Defira Metha DiandraProgram Studi : ApotekerJudul : Praktek Kerja Profesi di PT Darya-Varia Laboratoria Tbk Periode Januari-Februari 2017 Industri Farmasi adalah badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat. Pembuatan obat di Industri Farmasi harus sesuai dengan Cara Pembuatan Obat yang Baik CPOB untuk memastikan mutu obat yang dihasilkan konsisten, sesuai persyaratan, dan tujuan penggunaan. Praktek Kerja Profesi Apoteker PKPA di PT Darya Varia Laboratoria Tbk dilaksanakan pada tanggal 3 Januari hingga 28 Februari 2017. Tujuan pelaksanaan PKPA untuk memahami tugas dan tanggung jawab apoteker di Industri Farmasi, memiliki wawasan dan pengalaman praktis melakukan pekerjaan kefarmasian, memahami penerapan CPOB, serta mengetahui permasalahan kefarmasian di Industri Farmasi. Beberapa kegiatan yang dilakukan selama PKPA yaitu induksi ke bagian-bagian di perusahaan dan membantu pekerjaan di bagian Logistik untuk melakukan validasi dan verifikasi Database Incoming Material List. PT Darya-Varia Laboratoria Tbk telah menerapkan CPOB dalam kegiatan pembuatan obat mulai dari perencanaan, penyimpanan, produksi, pengemasan, hingga distribusi obat. Kata kunci : CPOB, Industri Farmasi, PT Darya-Varia Laboratoria TbkTugas umum : xi 46 halaman, 2 tabel, 2 lampiranTugas khusus : v 22 halaman, 8 gambar, 2 tabel, 2 lampiranDaftar acuan tugas umum : 3 2009 ndash; 2012 Daftar acuan tugas khusus : 3 2012 ndash; 2017

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ABSTRACTName Defira Metha DiandraStudy Program Apothecary ProfessionTitle Internship at Darya Varia Laboratoria Inc.Month Period January February 2017 Pharmaceutical Industry is a corporation that has a license from Minister of Health to manufacturing drugs. Manufacturing drugs or drugs material in Pharmaceutical Industry is obliged to comply with the requirements of Good Manufacturing Practice for Pharmaceuticals GMP to ensure the quality of drug is consistent, meet the requirements, and qualified for intended use. Profession internship at Darya Varia Laboratoria Inc. held on January 3rd to February 28th, 2017. The aims of profession internship are to understand the duties and responsibilities of pharmacist in Pharmaceutical Industry, to obtain knowledge and practical experience of undertaking pharmaceutical work, to understand the application of GMP, as well as knowing pharmaceutical issues in the Pharmaceutical Industry. Activities conducted during profession internship are induction into departments and assist the work at Logistics Department to validate and verify the Database of Incoming Material List. Darya Varia Laboratoria Inc. has implemented GMP in drug manufacturing activities from planning, storage, production, packaging, to distribution of drugs. Keywords Darya Varia Laboratoria Inc., GMP, Pharmaceutical IndustryGeneral assignment xi 46 pages, 2 tables, 2 appendicesSpesific assignment v 22 pages, 8 pictures, 2 tables, 2 appendicesBibliography of general assignment 3 2009 ndash 2012 Bibliography of specific assignment 3 2012 ndash 2017 "

"ABSTRAKPraktek Profesi Apoteker di PT Darya Varia Laboratoria Tbk bertujuan untuk memahami peran, tugas dan tanggung jawab Apoteker di Industri Farmasi, mampu memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi, memahami penerapan Cara Pembuatan Obat yang Baik CPOB di PT Darya Varia Laboratoria, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Praktek kerja profesi dilakukan selama dua bulan di bagian Quality Assurance. Pada pelaksanaan praktek kerja terdapat tugas khusus berupa analisis data peninjauan mutu produk X untuk tren data hasil hasil analisis, raw material dan packaging material.

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ABSTRACTThe aims of internship at PT Darya Varia Laboratoria was to understand the roles, duties and responsibilities of pharmacist in Pharmaceutical Industry, gaining knowledges, skills, practical experiences, to understand the implementation of Good Manufacturing Practice GMP in PT Darya Varia Laboratoria and perspectives about pharmaceutical practice issue in Pharmaceutical Industry. The internship was held for two months in Quality Assurance department. The specific assignment was about analysis of product quality review of X product for trend of data results of analysis, raw material and packaging material. "

"Peran Apoteker di industri farmasi merupakan hal penting di mana industri farmasi wajib memiliki setidaknya tiga orang apoteker penanggung jawab masing-masing pada bidang pemastian mutu, produksi, dan pengawasan mutu. Praktik kerja profesi dilaksanakan bertujuan untuk calon apoteker dapat memahami peranan, tugas, dan tanggung jawab apoteker di industri farmasi, serta mendapatkan wawasan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi. Praktik kerja dilaksanakan di PT Darya-Varia Laboratoria Tbk Plant Gunung Putri selama dua bulan pada Bulan Januari hingga Februari 2018. Salah satu aspek dalam CPOB adalah dokumentasi, di mana dokumentasi yang baik, contohnya batch record, merupakan bagian penting dari pemastian mutu. Belum adanya sistem penyimpanan batch record melatarbelakangi dilakukannya pemetaan ruang dan pendataan lokasi penyimpanan batch record sebagai tugas khusus dalam praktik kerja profesi ini. Dilaksanakannya tugas khusus ini memberikan kemudahan personil dalam mencari batch record dalam waktu yang cepat sehingga penyelesaian masalah yang membutuhkan penelusuran catatan produksi dapat dilakukan dengan lebih cepat.

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The role of pharmacists in the pharmaceutical industry is essensial in which the pharmaceutical industry is required to have at least three respective pharmacists in the areas of quality assurance, production and quality control. The internship conducted was aimed at the prospective pharmacist to understand the role, duties and responsibilities of pharmacists in the pharmaceutical industry, and to gain knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry. The internship was held at PT Darya-Varia Laboratoria Tbk Plant Gunung Putri for two months in January to February 2018. One aspect of the CPOB is documentation, where good documentation, for example batch record, is an important aspect of quality assurance. The absence of a batch record storage system became the background to perform the mapping of batch record storage room and set the database of batch record storage location as a project and special assignment during internship. The application of this project gave ease to any concerned personnel in finding batch records in quick time so that tracking of batch records in order to solve the pharmacy industrial problem can be done more quickly."

"ABSTRAKPraktek kerja profesi di PT. Kalbe Farma, Tbk. Periode Bulan Januari - Februari Tahun 2017 bertujuan untuk mengetahui tugas dan tanggung jawab apoteker di industri farmasi dan memahami penerapan Cara Pembuatan Obat yang Baik CPOB di Industi Farmasi. Selain itu calon apoteker juga dapat memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi. Praktek kerja profesi di PT. Kalbe Farma, Tbk dilakukan selama delapan minggu dengan tugas khusus yang diberikan yaitu berjudul ldquo;Pembuatan Protokol Validasi Proses Produksi Tablet X rdquo;. Tujuan dari tugas khusus ini adalah agar calon apoteker dapat membuat protokol validasi proses. Secara umum, PT. Kalbe Farma, Tbk. 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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ABSTRACTInternship at PT. Kalbe Farma, Tbk. month period January February 2017 aims to understand the duties and responsibilities of pharmacists in the pharmaceutical industry and the understanding of the application of good manufacturing practice GMP 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. Practice professional work in PT. Kalbe Farma, Tbk. conducted for eight weeks with a special assignment given is ldquo Creation Protocol Validation Process of Tablet X rdquo . The purpose of this special assignment is the pharmacist candidate can create a protocol validation process. In general, PT. Kalbe Farma, Tbk. 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"

"Praktik kerja profesi di PT Darya-Varia Laboratoria Tbk Plant Gunung Putri Periode Januari ndash; Februari 2018 bertujuan untuk memberikan pemahaman pada calon apoteker mengenai peranan, tugas dan tanggung jawab seorang apoteker di industri farmasi. Praktik kerja profesi ini juga bertujuan untuk memberikan wawasan, pengetahuan, ketrampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi. Praktik kerja profesi juga memberikan gambaran mengenai penerapan Cara Pembuatan Obat yang Baik CPOB dan gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Praktik kerja profesi dilakukan selama dua bulan di Departemen Quality Assurance bagian Calibration/Validation. Selama menjalani praktik kerja profesi, diberikan tugas khusus yaitu ldquo;Mapping Temperatur dan Kelembaban Ruang Stripping pada Area Produksi Soft Capsule rdquo; yang bertujuan untuk mengetahui titik terburuk dari ruangan stripping yang akan digunakan sebagai tempat meletakan termohigrometer untuk monitoring harian.

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Internship at PT Darya-Varia Laboratoria Tbk Plant Gunung Putri Period January ndash; February 2018 aims to give an understanding to the apothecary candidate about roles, tasks, and responsibilities an apotechary in pharmaceutical industry. Internship aims to give knowledges, skils, and experiences to do pharmaceutical jobs in pharmaceutical industry. Internship also gives an insight of the application of Good Manufacturing Practice GMP and insight of the real problem in pharmaceutical jobs in pharmaceutical industry. Internship was conducted for two months in Quality Assurance Department, in Calibration/Validation division. Special assignment was given about ldquo;Mapping Temperature and Relative Humidity of Stripping Rooms on Soft Capsule Production Area rdquo; that aims to know the worst point of the stripping rooms that will be used as the place to place thermohigrometer for daily monitoring."

"ABSTRAKPraktik kerja profesi di PT Darya-Varia Laboratoria Tbk Periode Bulan Maret ndash; April Tahun 2018 bertujuan untuk mengetahui tugas dan tanggung jawab apoteker di industri farmasi dan memahami penerapan Cara Pembuatan Obat yang Baik CPOB di Industi Farmasi. Selain itu calon apoteker juga dapat memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang diberikan yaitu berjudul ldquo;Standardisasi Penyimpanan, Perawatan, Inspeksi, dan Pendataan Spare Part serta Peralatan di Area Produksi GP Solid rdquo;. Tujuan dari pelaksanaan tugas khusus di PT Darya-Varia Laboratoria Tbk adalah melakukan pemastian terhadap kegiatan penyimpanan, perawatan, inspeksi, dan pendataan spare part dan melakukan pembuatan working instruction sesuai dengan hasil observasi. Secara umum, PT Darya ndash;Varia Laboratoria Tbk 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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ABSTRACTInternship at PT Darya-Varia Laboratoria Tbk Period March ndash; April 2018 aims to understand the duties and responsibilities of pharmacists in the pharmaceutical industry and the understanding of the application of good manufacturing practice GMP 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. The special assignment given is Standardization of Storage, Maintenance, Inspection, and Data Collection of Spare Parts and Equipment in the GP Solid Production Area . The purposes of carrying out special assignment at PT Darya-Varia Laboratoria Tbk are to ensure the activities of storing, maintaining, inspecting, and collecting data of spare parts and making working instructions in accordance with the results of observation. In general, PT Darya-Varia Laboratoria Tbk 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. "

" ABSTRAKNama : Elizabeth Greffiana ChandraNPM : 1206260330Program Studi : Profesi ApotekerJudul : Praktik Kerja Profesi di PT Mahakam Beta Farma Periode Bulan Januari ndash; Februari Tahun 2017 Praktik Kerja Profesi di PT Mahakam Beta Farma bertujuan agar calon apoteker mampu memahami peranan, tugas dan tanggung jawab apoteker di Industri Farmasi; memperoleh wawasan, pengetahuan, keterampilan, dan pengalaman praktis dalam menjalankan pekerjaan kefarmasian di Industri Farmasi; memahami penerapan GMP dan Cara Pembuatan Obat yang Baik CPOB di Industri Farmasi; serta memperoleh gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Adapun Tugas Khusus yang diberikan berjudul lsquo;Penanganan CAPA di PT Mahakam Beta Farma rsquo; bertujuan agar calon apoteker mampu mengetahui dan memahami Prosedur Tetap CAPA yang berlaku di PT Mahakam Beta Farma; mengetahui kesesuaian antara implementasi proses penanganan CAPA di PT Mahakam Beta Farma dengan Protap yang berlaku; mengetahui dan memahami pelaksanaan kegiatan monitoring CAPA di PT Mahakam Beta Farma; serta mengetahui dan memahami pelaksanaan kegiatan penilaian efektivitas CAPA di PT Mahakam Beta Farma. Kata Kunci : Apoteker, Industri Farmasi, CPOB, CAPATugas Umum : xii 46 halaman 1 gambar, 1 tabel, 7 lampiran Tugas Khusus : iii 19 halaman 4 lampiran Daftar Acuan Tugas Umum : 9 2008 ndash; 2013 Daftar Acuan Tugas Khusus : 6 2008 ndash; 2016

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ABSTRACTName Elizabeth Greffiana ChandraNPM 1206260330Study Program Apothecary ProfessionTitle Internship at PT Mahakam Beta Farma Month Period January ndash February 2017 Profession Internship at PT Mahakam Beta Farma aims for pharmacy student to understand the role, duties and responsibilities of pharmacists in the Pharmaceutical Industry gain insight, knowledge, skills and practical experience in performing pharmaceutical work in the Pharmaceutical Industry understand the application of GMP and Cara Pembuatan Obat yang Baik CPOB in the Pharmaceutical Industry as well as obtaining a clear picture of the pharmaceutical work problems in the Pharmaceutical Industry. The Special Task entitled 39 Penanganan CAPA di PT Mahakam Beta Farma 39 aims for pharmacy student to know and understand the CAPA Procedures applicable in PT Mahakam Beta Farma to know the suitability between the implementation of CAPA handling process in PT Mahakam Beta Farma with the prevailing procedures to know and understand the implementation of CAPA monitoring activities at PT Mahakam Beta Farma and also to know and understand the implementation of CAPA effectiveness assessment in PT Mahakam Beta Farma. Keywords Pharmacist, Pharmaceutical Industry, CPOB, CAPAGeneral Assignment xii 46 pages 1 pictures, 1 tables, 7 appendices Specific Assignment iii 19 pages 4 appendices Bibliography of General Assignment 9 2008 ndash 2013 Bibliography of Specific Assignment 6 2008 ndash 2016 "

"ABSTRAKNama : Alisa Nur OctavianiProgram Studi : FarmasiJudul : Praktik Kerja Profesi Apoteker di PT Ferron Par Pharmaceuticals Periode Bulan Januari-Februari Tahun 2017 Industri farmasi harus memiliki paling sedikit 3 tiga Apoteker sebagai penanggung jawab pemastian mutu, produksi dan pengawasan mutu. Selain itu, industri farmasi harus memenuhi pesyaratan CPOB dimana pemenuhan tersebut harus dibuktikan dengan adanya sertifikat CPOB yang berlaku selama 5 lima tahun selama industri farmasi tersebut memenuhi persyaratan. Selain tempat pembuatan obat/ bahan obat, industri farmasi memiliki fungsi lain yaitu sebagai tempat pendidikan/pelatihan dan penelitian serta pengembangan. Praktek kerja profesi di PT Ferron Par Pharmaceuticals bagian GMP Training merupakan salah satu bentuk pelatihan lapangan kepada para calon Apoteker. Peran Apoteker di GMP Training yaitu melakukan pembuatan desain matriks dan materi training lalu membuat jadwal training yang selanjutnya memberikan rekomendasi karyawan atau karyawan baru dari hasil training tersebut. Tugas Khusus yang diberikan adalah melakukan pembuatan materi training mengenai tata cara bekerja di laboratorium kimia dan manual peak integration. Pembuatan materi dilakukan dengan media presentasi dalam bentuk power point. Berdasarkan kegiatan pembuatan materi dapat disimpulkan bahwa materi training yang dibuat ditujukan terutama untuk para analis dan labtek yang berkepentingan melakukan kegiatan teknis di laboratorium kimia. Kata Kunci : CPOB Cara Pembuatan obat yang Baik , GMP Training, Industri Farmasixii 63 halaman : 1 gambar, 1 tabel, 7 lampiranAcuan : 6 2009-2013

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ABSTRACTName Alisa Nur OctavianiStudy Program PharmacyTitle Internship at PT Ferron Par Pharmaceuticals month period January February 2017 Pharmaceutical industry should have minimum 3 Pharmacist as person in charge or manager for quality assurance, production and quality control. In addition, pharmaceutical industry must meet the requirement of GMP which is evidenced by the existence of a certificate of GMP that last up to 5 years As long as the pharmaceutical industry still meets the requirements. Pharmaceutical industry not only a place for manufacturing of drugs or raw material but also has other function as a place of education training and research and development. Internship at sub departement GMP Training of PT Ferron Par Pharmaceuticals is a way of learning about the real world of work for apothecary student. The role of pharmacist in GMP Training is to make matrix design and training materials then create a training schedule which further gives recommendations of new employees or employees of the training results. The special assignment is to make training material about how to work in chemical laboratory and manual of peak integration. Training material was done with the media presentation in the form of power point. Based on the material making activities, it can be concluded that the training materials that are made are aimed primarily for analysts and laboratory technician who are interested in doing technical activities in chemical laboratories. Keywords Good Manufarcturing Practice, GMP Training, Pharmaceutical Industryxii 63 pages 1 pictures, 1 tables, 7 appendixesBibliography 6 2009 2013 "

"Praktik Kerja Profesi Apoteker di PT Darya-Varia Laboratoria Tbk PlantCiteureup untuk memperoleh wawasan dan gambaran langsung mengenaipenerapan aspek – aspek Cara Pembuatan Obat yang Benar di dalam IndustriFarmasi. Praktik kerja juga membuat seorang calon apoteker dapatmendalami peran dan tugas apoteker di dalam industri farmasi, tidak hanyasebagai personil kunci namun posisi –posisi yang mendukung di dalamnya.Tugas khusus dari kegiatan Praktik Kerja Profesi Apoteker adalahmenambah pengetahuan mahasiswa mengenai validasi proses pengemasanprimer sediaan solid; memahami pelaksanaan validasi proses di PT Darya-Varia Laboratoria ; dan menambah pengetahuan tentang parameter kritis danatribut kualitas yang terkait dengan proses pengemasan primer sediaan solid.

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Pharmacist Internship Program at PT Darya-Varia Laboratoria Tbk Citeureup

Plant objective is for the pharmacist to gain the knowledge and experience

about the practice of Good Manufacturing Practices in Pharmaceutical

Industry. This Internship Program allowed student to conceive pharmacist

role in the pharmaceutical industry not only as a key personnel but also as other role that support the Industry. The objective of the specialized

assignments are to conceive validation process of primary packaging of solid dosage form; to conceive the implementation of validation process in PT Darya-Varia Laboratoria; and to add knowledge about critical parameters and quality atributes related into the primary packaging validation process of solid dosage form."