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"Industri Farmasi adalah badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat dan bahan obat. Pemerintah Indonesia melalui Keputusan Menteri Kesehatan No.43/Menkes/SK/II/1988 tentang Cara Pembuatan Obat yang Baik (CPOB) berusaha menjamin mutu obat yang dihasilkan industri farmasi meliputi serangkaian kegiatan produksi hingga obat jadi yang dihasilkan memenuhi syarat dan sesuai dengan tujuan penggunaannya. Penerapan pedoman CPOB ini diharapkan dapat meningkatkan mutu produk obat secara terus menerus dan memberikan perlindungan terhadap kesehatan masyarakat serta menjadi langkah progresif bagi perkembangan industri farmasi di Indonesia sehingga mendapat pengakuan dan kepercayaan dari konsumen. Oleh karena itu, apoteker harus memiliki kompetensi yang baik dalam menjamin pelaksanaan CPOB berjalan sesuai persyaratan. Praktek Kerja Profesi Apoteker (PKPA) yang dilakukan pada 9 September - 31 Oktober 2013 di PT. Taisho Pharmaceutical Indonesia Tbk. dalam rangka memperoleh pengetahuan dan wawasan mengenai penerapan aspek-aspek CPOB di PT. Taisho Pharmaceutical Indonesia Tbk. serta memahami peran dan tugas apoteker dalam industri farmasi.

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Pharmaceutical Industry is an entity that has the permission of the Minister of Health to conduct the manufacture of drugs and drug ingredients. Indonesian Government through the Minister of Health No.43/Menkes/SK/II/1988 on Good Manufacturing Practice (GMP) seeks to ensure the quality of drug produced by the pharmaceutical industry includes the production of a series of events to be generated drug and qualified in accordance with the intended use. The application of GMP guidelines is expected to improve the quality of drug products continuously and provide protection to public health as well as being a progressive step for the development of the pharmaceutical industry in Indonesia, so it gets the recognition and trust of consumers. Therefore, pharmacists must have a good competence in ensuring the implementation goes according to GMP requirements. Pharmacist Internship Program (PKPA) conducted on September 9th to October 31th 2013 in the PT. Taisho Pharmaceutical Indonesia Tbk. in order to gain knowledge and insight about the implementation aspects of GMP in PT. Taisho Pharmaceutical Indonesia Tbk. and understand the role and duties of the pharmacist in the pharmaceutical industry."

"Pharmaceutical Industry is the place to meet the needs of public health by increasing the quantity and quality of the drug to be in production All drugs are in production and will be circulated to be guaranteed safety efficacy and quality To achieve this we need a guideline that covers all aspects of production and quality control in order to ensure the drug is made consistently meeting the requirements set out and in accordance with their intended use namely the Good Manufacturing Practice GMP All GMP pharmaceutical industry shall apply in all aspects and activities of a series of drug manufacturing Work Practice Pharmacist PKPA conducted during the period 17 June to 30 August 2013 in the PT Taisho Pharmaceutical Indonesia Tbk to provide supplies for prospective pharmacists to apply the knowledge they have learned during the course in a practical and direct the quality control of drugs in the Pharmaceutical Industry The PKPA activities aimed to compare the application of the provisions of the implementation of GMP in Pharmaceutical Industry particularly in PT Taisho Pharmaceutical Indonesia Tbk dan understand the duties and responsibilities of pharmacists in the Pharmaceutical Industry is mainly in charge of production quality assurance and quality control "

"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 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 apoteker di PT. Taisho Pharmaceutical Indonesia, Tbk. bertujuan untuk memahami peran dan tanggung jawab apoteker dalam industri farmasi, meningkatkan wawasan dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi dalam berbagai aspek, dan memahami penerapan Cara Pembuatan Obat yang Baik CPOB . Tujuan lainnya yaitu penulis diharapkan memiliki gambaran nyata tentang permasalahan pekerjaan kefearmasian di industri farmasi. Praktek kerja profesi dilakukan selama dua bulan disertai dengan pengerjaan tugas khusus berupa kegiatan membuat prosedur tetap proses produksi dan pengemasan produk investigasional untuk uji klinik. Tujuan dari tugas khusus ini adalah mengetahui mekanisme dalam pembuatan dokumen di bagian pemastian mutu dan melakukan pembuatan protap baru yaitu protap produksi pengemasan produk investigasional untuk uji klinik dimana uji klinik dilakukan sebagai syarat untuk mendapatkan nomor registrasi.

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ABSTRACTThe aims of pharmacist internship in PT. Taisho Pharmaceutical Indonesia, Tbk. were to understand about the role and responsibility of pharmacist in pharmaceutical industry, to enhance knowledge and practical experience to do pharmaceutical work in pharmaceutical industry in various aspects, and to understand the application of Good Manufacturing Practice GMP . Another goal was the authors have a real representation about the problem of pharmaceutical work in the pharmaceutical industry. The internship was held in two months include a specific assignment about creating a Standard Operating Procedure SOP for production and packaging of investigational products for clinical trials. The purpose of this specific assignment were to know the mechanisms in the preparation of documents in the quality assurance section and to make a new document that is SOP of production and packaging of investigational products for clinical trials where clinical trials are conducted as requirement to get registration number."

"Praktek Kerja Profesi Apoteker dilaksanakan di PT. Taisho Pharmaceutical Indonesia Tbk., bertujuan agar mahasiswa profesi apoteker dapat meningkatkan pengetahuan dan wawasan mengenai CPOB dalam segala aspek pada industri farmasi terutama penerapan CPOB di PT. Taisho Pharmaceutical Indonesia Tbk., serta mengetahui dan memahami peran dan tanggung jawab Apoteker dalam industri farmasi yang diharapkan dapat menjadi bekal untuk menghadapi dunia kerja yang sesungguhnya. Tugas khusus yang diberikan berjudul Simplifikasi Dokumen Manufacturing Instruction (MI), Packaging Instruction (PI), dan Laboratory Report. Tugas khusus ini bertujuan untuk menyederhanakan ketiga dokumen tersebut sehingga menghindari pengisian dokumen dengan informasi yang sama secara berulang-ulang.

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Pharmacist internship at PT. Taisho Pharmaceutical Indonesia Tbk., aims to improve pharmacist student’s knowledge and insight regarding all aspects of GMP in the pharmaceutical industry, especially the implementation of GMP in PT. Taisho Pharmaceutical Indonesia Tbk., and to know and understand the roles and responsibilities of pharmacists in the pharmaceutical industry. It is expected to help pharmacist student to face the real working world. The special task is about simplification of Manufacturing Instruction (MI), Packaging Instruction (PI), and the Laboratory Report. This special task aims to simplify the those documents thus avoiding the charging document with the same information repeatedly."

"Seorang Apoteker harus memenuhi standar kompetensi sebagai persyaratan untuk memasuki dunia kerja dan menjalani praktik profesi. Standar kompetensi apoteker Indonesia terdiri dari sepuluh standar kompetensi sebagai kemampuan yang diharapkan oleh apoteker saat lulus dan masuk ke tempat praktik kerja profesi. Calon apoteker harus memiliki pengalaman praktis agar dapat memahami peran apoteker dan meningkatkan kompetensi yang dimiliki. Oleh karena itu, Fakultas Farmasi Universitas Indonesia bekerjasama dengan beberapa pihak untuk melaksanakan Praktik Kerja Profesi Apoteker di bidang industri, pemerintahan, dan pelayanan. Praktik Kerja Profesi Apoteker ini diselenggarakan dalam tiga periode. Periode pertama dilaksanakan di PT Pharmaceutical Indonesia pada Bulan Januari-Maret Tahun  2019.  Periode kedua dilaksanakan di Suku Dinas Kesehatan Jakarta Timur pada Bulan Maret  Tahun  2019. Periode ketiga dilaksanakan di Apotek Safa pada Bulan April  Tahun  2019. Selama  kegiatan Praktik Kerja Profesi Apoteker  diharapkan  calon  apoteker  dapat memperluas wawasan, pemahaman, dan pengalaman untuk meningkatkan kompetensi dalam melakukan pekerjaan kefarmasian pada masing-masing tempat Praktik Kerja Profesi Apoteker.

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A Pharmacist must meet competency standards as a requirement for entering the workforce and undergoing professional practice. Indonesian pharmacist competency standards consist of ten competency standards as abilities expected by pharmacists when they graduate and enter professional work practices. Prospective pharmacists must have practical experience in order to understand the role of pharmacists and improve their competence. Therefore, the Faculty of Pharmacy, University of Indonesia in collaboration with several parties to implement the Pharmacist Professional Work Practices in the fields of industry, government, and services. Pharmacist Professional Work Practices are held in three periods. The first period was held at PT Pharmaceutical Indonesia in January-March 2019. The second period was carried out at the East Jakarta Health Service Tribe in March 2019. The third period was carried out at Safa Pharmacy in April 2019. During the Pharmacist Professional Work Practices activities it is expected that candidates pharmacists can broaden their insights, understandings, and experiences to improve their competence in carrying out pharmaceutical work in each of the Pharmacist Professional Work Practices."

"Praktek kerja profesi apoteker di PT Taisho Pharmaceutical Indonesia Tbk dilakukan agar calon apoteker mendapatkan bekal pengetahuan dan pengalaman yang memadai untuk melakukan pekerjaan kefarmasian serta aplikasi prinsip CPOB di Industri farmasi Tugas khusus yang dikerjakan berjudul Evaluasi Prosedur Tetap Penyiapan dan Penanganan Logbook di PT Taisho Pharmaceutical Indonesia Tbk Evaluasi dilakukan untuk menghilangkan sesuatu yang tidak diperlukan yang bersifat ganda serta melengkapi kelengkapan data yang penting untuk dijadikan focus utama Hasil dari evaluasi yang dilakukan adalah benrtuk standar format logbook dan prosedur tetapnya yang diaplikasikan di senua departemen di PT Taisho Pharmaceutical Indonesia Tbk

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Pharmacists Professional Practice at PT. Taisho Pharmaceutical Indonesia Tbk., aims to make the pharmacist candidate got enough experience and education to do the pharmaceutical jobs and also the application of GMP in pharmaceutical industry. The special assignment was evaluation of standard operational and procedure about preparation and management of logbook at PT. Taisho Pharmaceutical Indonesia Tbk., The evaluation aims to eliminate the unwanted things that doubled and also to complete the data needed that use as the main focus. The result of this evaluation is standardize logbook and the standard operation and procedure that applicable in all department in PT. Taisho Pharmaceutical Indonesia Tbk."

"ABSTRAKPraktek kerja profesi apoteker di PT. Taisho Pharmaceutical bertujuan untuk mengetahui peran serta tanggung jawab apoteker dalam industri farmasi. Peranan penting apoteker di industri farmasi antara lain dalam proses produksi, pengendalian mutu dan pemastian mutu dari produk farmasi yang dihasilkan. Pada proses produksi, salah satu peran apoteker adalah menjamin proses produksi dijalankan sesuai dengan Cara Pembuatan Obat yang Baik. PT. Taisho Pharmaceutical melakukan simplifikasi pada proses set up dan cleaning total yang mengacu pada lean manufacturing. Selama program praktik kerja ini, telah berhasil dilakukan simplifikasi proses set up dan cleaning total pada mesin filling IWKA dari beberapa produk seperti myco-z cream, daktarin cream 5 gram.

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ABSTRACTPharmacist internship in PT. Taisho Pharmaceutical aims to know the role and responsibility of pharmacists in the pharmaceutical industry. The important role of pharmacists in the pharmaceutical industry, among others, in the production process, quality control and quality assurance of pharmaceutical products produced. In the production process, one of the pharmacists 39 role is to ensure the production process is executed in accordance with Good Manufacturing Practice. PT. Taisho Pharmaceutical simplifies the total set up and cleaning process that refers to lean manufacturing. During this practical work program, there has been a complete simplification of set up and cleaning process on IWKA filling machine from some products such as myco z cream, daktarin cream 5 gram."

"ABSTRAKPraktek kerja profesi Apoteker di PT. Taisho Pharmaceutical Indonesia, Tbk. bertujuan untuk mengetahui peran, tugas dan tanggung jawab Apoteker di Industri Farmasi, memiliki wawasan, pengetahuan, ketrampilan dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi; memahami penerapan CPOB di Industri Farmasi dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Indsutri Farmasi. Selama PKPA,mahasiswa dibekali dengan training CPOB, sertifikat halal, dan EHS Environment, Health, and Safety , serta ditempatkan di Pengawasan Mutu. Kegiatan di Pengawasan Mutu adalah melakukan verifikasi metode pengujian yang dilakukan oleh analis terhadap dokumen spesifikasi dan metode pengujian produk jadi yang bersumber dari Farmakope Indonesia dan United State Pharmacopeia USP . Kegiatan lainnya adalah melakukan analisis terhadap biaya yang dikeluarkan untuk pengujian produk jadi. Berdasarkan PKPA yang telah dilakukan, dapat disimpulkan bahwa Apoteker di PT. Taisho Pharmaceutical Indonesia, Tbk. mempunyai peranan, tugas, dan tanggung jawab poada bagian produksi, pengawasan mutu, dan pemastian mutu.

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ABSTRACTInternship in PT Taisho Pharmaceutical Indonesia, Tbk. aims to understand the role, duties, and responsibilities of apothecary in the pharmaceutical industry, have the insight, knowledge, skills, and practical experience to do the work of Apothecary in the pharmaceutical industry, understanding the application of GMP in the pharmaceutical industry, and have a real picture of the problems of pharmaceutical jobs in the pharmaceutical industry. During internship, students are equipped with the training of GMP, Halal certificate, and EHS Environment, Health, and Safety , and placed in the Quality Control. Activities in quality control is to verify the testing method undertaken by the analyst against the spesification document and test method of the finished good product originating from Pharmacopeia Indonesia and United State Pharmacopeia USP . Another activity is to analyze the costs incurred for testing the finished product. Based on internship that the pharmacist at PT. Taisho Pharmaceutical Indonesia, Tbk. has a role, duties, and responsibilities in production, quality control, and quality assurance."