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"ABSTRAKPraktik kerja profesi di Praktek Kerja Profesi di PT. Mahakam Beta Farma Periode Bulan Juli Hingga Agustus 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. Tugas khusus yang diberikan yaitu berjudul ldquo;Reformulasi Bahan Penyalut Larut Organik dengan Bahan Penyalut Water Base pada Tablet Salut Clopidogrel rdquo;. Tujuan dari tugas khusus ini adalah membuat reformulasi bahan salut pada tablet salut clopidogrel dalam upaya peningkatan kualitas dan keamanan mutu obat pada produk tablet salut clopidogrel dengan mengganti larutan penyalut dari solvent dan bahan penyalut organik menjadi water base.

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ABSTRACTInternship at PT. Mahakam Beta Farma month period July-August 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. The special assignment given is Reformulation of Organic Solvent Coating Material with Water Base Coating Material on Clopidogrel Coat Tablet . The objective of this particular task is to make a reformulation of coat on clopidogrel coated tablets in an effort to improve the quality and safety of the drug in clopidogrel coated tablets by replacing the coating solution from solvent and organic coating agent to water base coating agent. "

"ABSTRAKPraktik Kerja Profesi Apoteker PKPA dilaksanakan di PT Mahakam Beta Farma pada 03 Juli 2017 hingga 31 Agustus 2017. Tujuan dilaksanakannya Praktik Kerja Profesi di Industri Farmasi PT Mahakam Beta Farma agar calon Apoteker mampu memahami 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. Kegiatan yang dilakukan selama praktik kerja profesi di PT Mahakam Beta Farma meliputi pemberian materi basic GMP, safety induction, profil perusahaan dan struktur organisasi perusahaan, plan tour, induction tiap-tiap departemen di PT Mahakam beta Farma, penempatan di Departemen Validasi, pengerjaan tugas khusus berupa Kualifikasi Kinerja, dan presentasi akhir.

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Internship at PT. Mahakam Beta Farma was started on July, 3rd 2016 to August, 31th 2016. This internship was intended to make Apothecary student understand roles and responsibilities of Pharmacist in Pharmaceutical Industry; to get insights, knowledges, skills, and practical experience to perform pharmaceutical practice; understand to apply of GMP in Pharmaceutical Industry, and to gets an overview about pharmaceutical practice issues in Pharmaceutical Industry. Activity at PT Mahakam Beta Farma were basic GMP materials, safety induction, profile of the company and organization structure, plan tour, induction at department at PT Mahakam Beta Farma, placement at Validation Department, performance qualification for special assignment and final presentation."

"ABSTRAKIndustri farmasi merupakan suatu badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat. Industri farmasi dalam menjalankan seluruh kegiatannya wajib memenuhi persyaratan Cara Pembuatan Obat yang Baik CPOB . Praktek Kerja Profesi PKP yang dilaksanakan di PT. Mahakam Beta Farma pada bulan Januari ndash; Februari 2017 bertujuan 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. Mahakam Beta Farma; induksi ke departemen yang berkaitan dengan seluruh kegiatan pembuatan obat; dan membantu beberapa pekerjaan di Departemen QC seperti membuat revisi Prosedur tetap dan instruksi kerja, mengerjakan penutupan CAPA Corrective Action Preventive Action , membuat Catatan Pemeriksaan Produk, serta membuat Performance Quality Review. PT. Mahakam Beta Farma merupakan industri farmasi yang telah melaksanakan prinsip CPOB dengan baik dalam setiap kegiatan yang dilakukan, baik dalam proses produksi, pengawasan dan pemastian mutu, serta kegiatan lain yang terkait.

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ABSTRACTPharmaceutical industry is a corporation that has a license from Minister of Health to manufacturing of drugs or drug materials. The pharmaceutical industry in carrying out all its activities shall meet the requirements of Good Manufacturing Practice for Pharmaceuticals GMP . Profession internship at PT. Mahakam Beta Farma in January February 2017 aims to gain 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. Mahakam Beta Farma induction into department which related drug manufacturing activities and and assist some work in the QC Department such as making revisions Fixed procedures and work instructions Working on CAPA Corrective Action Preventive Action closure Making Notes on Product Inspection And make Performance Quality Review. PT. Mahakam Beta Farma is a pharmaceutical industry that has implemented the GMP guidelines in each of activities, both in production process, control and quality assurance, and other related activities."

"ABSTRAKPraktek Profesi Apoteker di PT Mahakam Beta Farma 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 Mahakam Beta Farma, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Praktek kerja profesi dilakukan selama dua bulan di bagian Quality Control. 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 Mahakam Beta Farma 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 Mahakam Beta Farma and perspectives about pharmaceutical practice issue in Pharmaceutical Industry. The internship was held for two months in Quality Control 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"

"ABSTRAKPraktek Profesi Apoteker di PT Mahakam Beta Farma 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 Mahakam Beta Farma, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Praktek kerja profesi dilakukan selama dua bulan di bagian Quality Control. 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 Mahakam Beta Farma 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 Mahakam Beta Farma and perspectives about pharmaceutical practice issue in Pharmaceutical Industry. The internship was held for two months in Quality Control 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"

" 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 "

"Obat merupakan bahan atau campuran yang digunakan sebagai penetapan diagnosis, pencegahan, penyembuhan, pemulihan, serta peningkatan kesehatan manusia. Oleh sebab itu produk yang dihasilkan industri farmasi harus dilakukan product quality review (PQR) yang dilakukan secara berkala terhadap semua produk farmasi yang terdaftar termasuk ekspor, untuk menilai standar kualitas masing-masing produk obat dengan melihat konsistensi proses yang ada, kesesuaian dari spesifikasi bahan awal, bahan pengemas hingga produk jadi. Hiperkolesterolemia adalah salah satu gangguan metabolisme lipid yang ditandai dengan peningkatan kadar kolesterol di dalam darah melebihi batas normal yang memiliki risiko kematian penyakit jantung koroner. Banyaknya pasien berkunjung dan melakukan swamedikasi di Apotek Roxy Pondok Labu untuk meredakan gejala hiperkolesterolemia yang dikeluhkannya. Sehingga perlu diketahui gambaran konsumsi obat hiperkolesterolemia dalam mengatasi keluhan pasien sehingga dapat dijadikan sebagai dasar pertimbangan bagi farmasis dalam melakukan kegiatan pengelolaan sediaan farmasi mulai dari perencanaan, pengadaan hingga pengendalian stok obat di Apotek Roxy Pondok Labu. Penyusunan Product Quality Review, dan gambaran konsumsi obat hiperkolesterolemia dilakukan pada saat Praktik Kerja Profesi Apoteker di PT Mahakam Beta Farma, dan Apotek Roxy Pondok Labu. Pengerjaan dilakukan pada periode Juli – Agustus, dan Oktober 2021.

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Drugs are substances or mixtures that are used as a diagnosis, prevention, cure, recovery, and improvement of human health. Therefore, for the products produced by the pharmaceutical industry, product quality review (PQR) must be carried out periodically on all registered pharmaceutical products including exports, to assess the quality standards of each drug product by looking at the consistency of the process used, the suitability of the specifications of starting materials, packaging materials to finished products. Hypercholesterolemia is a lipid metabolism disorder which is characterized by an increase in cholesterol levels in the blood that exceeds the normal limit which has a risk of death from coronary heart disease. Many patients visit and do self-medication at the Roxy Pondok Labu Pharmacy to relieve the symptoms of hypercholesterolemia that they complain about. So it is necessary to know the description of hypercholesterolemic drug consumption in overcoming patient complaints so that it can be used as a basis for consideration for pharmacists in carrying out pharmaceutical preparations management activities ranging from planning, procurement to drug stock control at Roxy Pondok Labu Pharmacy. Preparation of Product Quality Review, and description of hypercholesterolemia drug consumption was carried out during the Pharmacist Professional Work Practice at PT Mahakam Beta Farma, and Roxy Pondok Labu Pharmacy. Work is carried out in the period July – August, and October 2021."

"Industri farmasi merupakan badan usaha yang memiliki izin untuk melakukan kegiatan pembuatan obat atau bahan obat. Untuk menjamin mutu obat yang dihasilkan, industri farmasi wajib menerapkan Cara Pembuatan Obat yang Baik CPOB . Apoteker merupakan salah satu aspek penting yang diatur dalam CPOB. Apoteker berperan sebagai personil kunci dalam industri farmasi yaitu sebagai kepala bagian produksi, kepala bagian pemastian mutu, dan kepala bagian pengawasan mutu. Praktik kerja profesi yang dilaksanakan di PT Mahakam Beta Farma dilaksanakan untuk membantu calon apoteker mendapat pengetahuan serta pengalaman praktik di industri farmasi. Pada praktik kerja ini juga dilakukan pelaksanaan tugas khusus yaitu pembuatan Pengkajian Mutu Produk PMP . Pembuatan PQR dilakukan dengan tujuan untuk melihat tren data dalam suatu periode, mengidentifikasi perbaikan yang diperlukan untuk produk serta membuktikan konsistensi proses, kesesuaian dari spesifikasi bahan awal, bahan pengemas, dan obat jadi.

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Pharmaceutical industry is a business entity that has permission to perform activities of making drugs or medicinal materials. To ensure the quality of the drugs produced, the pharmaceutical industry is obliged to apply Good Manufacturing Practice GMP . Pharmacists are one of the important aspects regulated in the GMP. Pharmacists serve as key personnel in the pharmaceutical industry as head of production, head of quality assurance, and head of quality control. The internship at PT Mahakam Beta Farma are conducted to help prospective pharmacists gain knowledge and experience in the pharmaceutical industry. This internship also carried out specific assignment, making Product Quality Review PQR . PQR is performed in order to look at data trends over a period, identify the necessary improvements to the product as well as prove the consistency of the process, the suitability of the specification of starting materials, packing materials and finished drugs. "

"Apoteker memiliki peranan penting di dalam industri farmasi, apotek, dan pemerintahan. Pada tiap-tiap tempat tersebut, apoteker memiliki peranan yang berbeda-beda. Di dalam menjalankan peranannya tersebut, apoteker harus memenuhi Standar Kompetensi Apoteker Indonesia dan menjalani praktek kerja profesi. Terdapat 10 poin di dalam Standar Kompetensi Apoteker Indonesia yang harus dipenuhi supaya seorang apoteker di Indonesia dapat dikatakan terkualifikasi di dalam menjalankan tugasnya. Oleh sebab itu, untuk meningkatkan kompetensi dan memahami peranan apoteker secara nyata di dunia kerja maka dilakukan Praktik Kerja Profesi di PT Mahakam Beta Farma, Apotek Kimia Farma No. 96 Slipi, dan Suku Dinas Wilayah Kota Administrasi Jakarta Timur periode Januari-April 2019. Selama melaksanakan PKPA, calon apoteker diharapkan mampu memperluas wawasan, pemahaman, dan pengalaman untuk melakukan pekerjaan kefarmasian di tempat praktik kerja profesi.

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Pharmacists have an important role in the pharmaceutical industry, pharmacies and government. In each of these places, pharmacists have different roles. In order to carrying out this role, pharmacists must meet Indonesian Pharmacist Competency Standards and do the internship.There are 10 points in the Indonesian Pharmacist Competency Standards that must be met so that a pharmacist in Indonesia can be said to be qualified in carrying out their duties.Therefore, for increasing competencies and understanding the role of pharmacists in the real life, the internship is carried out at PT Mahakam Beta Farma, Apotek Kimia Farma No.96 Slipi, and The East Jakarta Administration City Health Office for the January-April 2019 period. During internship, future pharmacists are expected to be able to broaden their knowledges and experiences to do pharmaceutical practice in professional workplaces."