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"[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 ]"

"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 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 (PKP) di PT Kimia Farma Tbk. Unit Research and Development dilaksanakan pada periode 2 Februari - 13 Maret 2015, bertujuan agar mahasiswa calon apoteker mengerti peranan, tugas, dan tanggung jawab Apoteker di industri farmasi khususnya di PT Kimia Farma Tbk. Unit Research and Development, memahami penerapan CPOB di industri farmasi, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Pada PKP ini juga diberikan tugas khusus yaitu berupa studi preformulasi dan formulasi tablet vitamin K3 (Menadion Natrium Bisulfit) 10 mg.

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ABSTRACTProfession Internship (PKP) at PT Kimia Farma Tbk. Research and Development Unit on February 2nd - March 13th 2015, aims to make students understand about the role of the prospective, duties, and responsibilities of pharmacist in pharmaceutical industries specifically in PT. Kimia Farma Tbk. Research and Development Unit, understanding the application of GMP in the in pharmaceutical industries, and have a real picture about the problem of pharmaceutical jobs in pharmaceutical industries. The special assignment of this PKP was preformulation and formulation study of Tablets Vitamine K3 (Menadione Sodium Bisulfite) 10 mg., Profession Internship (PKP) at PT Kimia Farma Tbk. Research and Development Unit on February 2nd - March 13th 2015, aims to make students understand about the role of the prospective, duties, and responsibilities of pharmacist in pharmaceutical industries specifically in PT. Kimia Farma Tbk. Research and Development Unit, understanding the application of GMP in the in pharmaceutical industries, and have a real picture about the problem of pharmaceutical jobs in pharmaceutical industries. The special assignment of this PKP was preformulation and formulation study of Tablets Vitamine K3 (Menadione Sodium Bisulfite) 10 mg.]"

"ABSTRAKPraktik Kerja Profesi Apoteker PKPA di PT. Taisho Pharmaceutical Indonesia,Tbk. bertujuan untuk mengetahui peran Apoteker di Industri farmasi danmeningkatkan pemahaman tentang semua aspek Cara Pembuatan Obat yang Baik CPOB di PT. Taisho Pharmaceutical Indonesia, Tbk.CPOB adalah cara pembuatan obat yang bertujuan untuk memastikan agar mutu obatyang dihasilkan sesuai dengan persyaratan dan tujuan penggunaan. CPOB terdiri dari12 Aspek dan 14 Anex. Peran Apoteker sebagai personil kunci yaitu sebagai kepalabagian pengawasan mutu, kepala bagian produksi dan kepala bagianpemastian mutu.Tugas khusus yang diberikan berjudul ldquo;Pembuatan spesifikasi dan metode pengujiandan catatan hasil pemeriksaan bahan baku dan bahan pengemas sebagai dokumentasipada bagian pengawasan mutu rdquo;. Secara keseluruhan PT. Taisho PharmaceuticalIndonesia, Tbk. telah melaksanakan CPOB dengan baik.

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ABSTRACTPharmacist Profession Practice Work PKPA at Atrika Pharmacy was conducted forone month. This activity aims to improve knowledge about pharmacy practices inPharmacy and to know the role of Pharmacists in Pharmacy. Pharmacists performpharmaceutical practices in pharmacy in accordance with Pharmaceutical ServiceStandards, ie pharmaceutical preparation management, medical devices and medicalconsumables and clinical pharmacy services. Management of pharmaceuticalpreparations, Medical Devices and Medical consumables includes planning,procurement, receipt, storage, destruction, control and reporting recording. Theclinical pharmacy services at Pharmacy include prescription assessment and services,dispensing, drug information services, counseling, monitoring of drug therapy, homepharmacy care, and monitoring of drug side effects. The role of Pharmacist inPharmacy as manager, professional and seller. The special assignment is entitled ldquo Draft of Pharmacy Cooperation with Doctor Practice that Serves Backward ReferralProgram PRB in Depok rdquo . Overall Pharmacists at Atrika Pharmacy have performedpharmaceutical practices well according to the applicable standards."

"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."

"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."

"Praktek 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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Internship 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."

"ABSTRAK Kesehatan merupakan hak dasar setiap individu dan setiap individu berhak untuk mendapatkan pelayanan kesehatan. Salah satu faktor yang mempengaruhi pelayanan kesehatan ialah ketersediaan dan kualitas obat yang sangat erat kaitannya dengan industri farmasi sebagai produsen obat. Untuk itu, setiap industri farmasi wajib memenuhi persyaratan CPOB (Cara Pembuatan Obat yang Baik). Dalam CPOB juga tertulis, bahwa terdapat tiga personil kunci yang bekerja dalam dunia industri farmasi yang merupakan seorang Apoteker. Oleh karena itu, calon Apoteker perlu untuk memahami secara langsung tugas dan tanggung jawab seorang Apoteker di industri farmasi melalui Praktek Kerja Profesi yang dilakukan di PT Taisho Pharmaceutical Indonesia, Tbk.

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ABSTRACTHealth is a fundamental right of every human being has the right to get a proper health care. An important factor that affect health care is the avalilabilty and quality of the drugs that are closely related to pharmaceutical industry as manufacturers. Therefore, every pharmaceutical industry shall meet the requirements of GMP (Good Manufacturing Practice). In GMP, there are three key personels who work in pharmaceutical industry which is a pharmacist. Therefore, a pharmacists need to understand the duties and responsibilities of a pharmacist who work in pharmaceutical industry through the internship at PT Taisho Pharmaceutical Indonesia, Tbk. "