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"Praktek Kerja Profesi Apoteker di PT. Taisho Pharmaceutical Indonesia, Tbk. memiliki tujuan agar calon Apoteker mampu 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 Cara Pembuatan Obat yang Baik CPOB di Industri Farmasi; dan memiliki gambaran nyata tentang permasalahan pekerjaan kefearmasian di Industri Farmasi. Tugas khusus yang diberikan berjudul Risk Assessment Prosedur Pembuatan, Pengendalian Bill of Material pada Sistem BPCS dan Pembuatan Shop Order Copy Prosedur Pengolahan dan Pengemasan Induk. Tujuan dari tugas khusus ini adalah agar mampu membuat risk assessment proses pembuatan dan pengendalian Bill of Material BOM pada sistem BPCS dan risk assessment pembuatan Shop Order Copy prosedur pengolahan dan pengemasan induk.

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Internship at PT. Taisho Pharmaceutical Indonesia, Tbk. aims for pharmacist candidate to be able to understand the roles, duties and responsibilities of pharmacists in pharmaceutical industry has the concepts, knowledges, skills, and practical experiences to perform pharmaceutical services in pharmaceutical industry understand the application of Good Manufacturing Practice GMP in pharmaceutical industry and has the clear vision about pharmaceutical service issues in pharmaceutical industry.

Given a special assignment titled Risk Assessment of the Making, Controlling Bill of Material on BPCS System Procedure and the Making of Shop Order Copy Manufacturing and Packaging Instruction. The purpose of this special assignment is to make risk assessment of the Bill of Material BOM creation and management process on the BPCS system, and risk assessment of Shop Order Copy Manufacturing and Packaging Instruction creation."

"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 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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Pharmacist 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 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."

"Kesehatan merupakan hak asasi manusia dan salah satu unsur kesejahteraan yang harus diwujudkan sesuai dengan cita-cita bangsa Indonesia. Pemeliharaan dan peningkatan kesehatan adalah hal yang selalu diupayakan manusia yang dapat diwujudkan dengan pembangunan fasilitas dan pemberian pelayanan kesehatan kepada masyarakat. Fasilitas yang diperlukan dimulai dari ketersediaan obat (industri farmasi), badan pengawasan obat serta pelayanan kefarmasian yang berorientasi pada pasien. Untuk itu diadakannya PKPA di PT Taisho Pharmaceutical Indonesia Tbk, BPOM RI, serta Apotek Kimia Farma Kartini 375 di tujukan untuk memberikan pengalaman kefarmasian secara langsung sehingga dapat meningkatkan kompetensi para calon Apoteker.

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Health is a human right and one of the elements of well-being that must be realized in accordance with the ideals of the Indonesian people. Maintenance and improvement of health is something that is always sought by humans that can be realized by the construction of facilities and the provision of health services to the community. The necessary facilities start from the availability of drugs (pharmaceutical industry), government and patient-oriented pharmaceutical services. For this reason, the holding of PKPA at PT Taisho Pharmaceutical Indonesia Tbk, BPOM RI, and Kimia Farma Kartini Pharmacy 375 is aimed at providing direct pharmaceutical experience so as to enhance the competency of prospective pharmacists"

"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."

"[ABSTRAKApoteker merupakan salah satu tenaga inti dalam industri farmasi yang turut berperan dalam menghasilkan obat yang bermutu aman dan berkhasiat CPOB mengemukakan bahwa terdapat beberapa kedudukan apoteker di industri yaitu Penanggung jawab produksi pengawasan mutu dan pemastian mutu Apoteker dituntut untuk mempunyai pengetahuan keterampilan dan kemampuan dalam mengaplikasikan dan mengembangkan ilmunya secara professional agar dapat mengatasi permasalahan permasalahan yang ada di industri farmasi Selama praktek kerja di PT Taisho Pharmaceutical Indonesia Tbk mahasiswa calon Apoteker dapat mengambil manfaat dan ilmu sebanyak mungkin mengenai industri farmasi sehingga dapat diaplikasikan dengan baik untuk pengembangan ilmu kefarmasian Tugas khusus yang didapatkan selama praktek kerja di PT Taisho Pharmaceutical Indonesia Tbk adalah membuat usulan standar prosedur operasional rework dan redress

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ABSTRACTPharmacists are one of the core force in the pharmaceutical industry that played a role in Generating drug quality safety and efficacy GMP argued that there are some pharmacists position in the industry which is undertaking production quality control and quality assurance Pharmacists are required to have the knowledge skills and ability to apply and develop their knowledge in a professional manner in order to overcome the problems that exist in the pharmaceutical industry During practice at PT Taisho Pharmaceutical Indonesia Tbk prospective pharmacist students may benefit as much knowledge as possible about the pharmaceutical industry so that it can be applied well to the development of pharmaceutical science Special task obtained during practise at PT Taisho Pharmaceutical Indonesia Tbk is making proposal of standard operational procedure of rework and redress , Pharmacists are one of the core force in the pharmaceutical industry that played a role in Generating drug quality safety and efficacy GMP argued that there are some pharmacists position in the industry which is undertaking production quality control and quality assurance Pharmacists are required to have the knowledge skills and ability to apply and develop their knowledge in a professional manner in order to overcome the problems that exist in the pharmaceutical industry During practice at PT Taisho Pharmaceutical Indonesia Tbk prospective pharmacist students may benefit as much knowledge as possible about the pharmaceutical industry so that it can be applied well to the development of pharmaceutical science Special task obtained during practise at PT Taisho Pharmaceutical Indonesia Tbk is making proposal of standard operational procedure of rework and redress ]"

"Praktek 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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Internship 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."

"Praktek 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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Internship 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."

"Industri farmasi merupakan industri yang menghasilkan produk kesehatan dan menunjang perwujudan kesehatan masyarakat, khususnya dalam pembuatan obat. CPOB merupakan syarat yang harus dipenuhi oleh industri farmasi dalam pembuatan obat untuk menjamin obat yang dihasilkan memenuhi standar kualitas, keamanan, dan khasiat. Apoteker, sebagaimana dalam CPOB, merupakan personil kunci di bagian produksi, pemastian mutu dan pengawasan mutu. Oleh karena itu, PT Taisho Pharmaceutical Indonesia, Tbk memberikan kesempatan bagi calon apoteker untuk menimba ilmu sehingga nantinya menjadi apoteker yang terkualifikasi dan memiliki pengalaman praktis untuk menghadapi era persaingan global.

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The pharmaceutical industry is an industry that produces health products and support the manifestation public health, especially in the manufacture of drugs. GMP is a requirement that must be fulfilled by the pharmaceutical industry in the manufacture of the drug to ensure drug produced and fulfill standard of quality, safety, and efficacy. Pharmacists, as in GMP, a key personnel in production, quality assurance and quality control. Therefore, PT Taisho Pharmaceutical Indonesia, Tbk provides an opportunity for prospective pharmacists to studying that will be a qualified pharmacist and practical experience to face global competition."

"Praktik kerja profesi di PT Taisho Pharmaceutical Indonesia Periode Bulan Februari - Maret 2020 bertujuan untuk 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 Cara Pembuatan Obat yang Baik (CPOB) di Industi Farmasi, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Sedangkan, praktek kerja profesi di Apotek Roxy Depok Periode Mei 2020 bertujuan agar calon apoteker memahami tugas dan tanggung jawab apoteker dalam pengelolaan apotek, serta melakukan praktek pelayanan kefarmasian sesuai dengan ketentuan perundang-undangan dan etika yang berlaku, memiliki wawasan, pengetahuan, keterampilan dan pengalaman praktis untuk melakukan praktik kefarmasian di apotek, memiliki gambaran nyata tentang permasalahan praktik kefarmasian serta mempelajari strategi dan kegiatan-kegiatan yang dapat dilakukan dalam rangka pengembangan praktik kefarmasian.

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Internship at PT Taisho Pharmaceutical Indonesia Period February - March 2020 aims to understand the duties and responsibilities of pharmacists in the pharmaceutical industry, have insight, knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry, and understanding of the application of good manufacturing practice (GMP) in the pharmaceutical industry. While, internship at Apotek Roxy Depok on May 2020 is intended to allow the apothecary profession students to directly understand the duties and responsibilities of pharmacists in pharmacy management, do the pharmaceutical practice accordance to laws and ethics, and fulfill the knowledge, skills, practical experience and also have the insight of pharmaceutical practice issues in the real conditition."