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"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."

"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 "

"Industri farmasi merupakan salah satu komponen penting yang bertanggung jawab terhadap mutu, khasiat, dan keamanan obat yang dikonsumsi oleh masyarakat. Cara Pembuatan Obat Yang Baik (CPOB) adalah pedoman kerja bagi industri farmasi di Indonesia untuk menyediakan obat yang berkualitas. Untuk mendukung persyaratan mutu yang ditetapkan tidak luput dari peran personil yang berperan di industri farmasi. Salah satu dari personil tersebut adalah apoteker. Peraturan Pemeritah nomor 51 tahun 2009 tentang Pekerjaan Kefarmasian menyebutkan bahwa setiap industri farmasi wajib mempunyai minimal tiga orang Apoteker berkewarganegaraan Indonesia yang menempati bagian produksi, pemastian mutu, dan pengawasan mutu. Oleh sebab itu, Fakultas Farmasi Universitas Indonesia bekerjasama dengan PT Taisho Pharmaceutical Indonesia Tbk untuk menyelenggarakan program Praktik Kerja Profesi Apoteker pada 9 September - 30 Oktober 2013. Tugas Khusus dengan judul "Titik Kritis Pada Proses Penimbangan, Pengolahan, Pengisian Hingga Pengemasan Produk Tempra®" bertujuan untuk mengetahui titik kritis pada proses produksi yang dapat mempengaruhi kualitas produk.

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The Pharmaceutical Industry is one of the main parts which are responsible for the quality, efficacy, and safety of drugs consumed by the public. Good Manufacturing Practice (GMP) is a working guideline for the pharmaceutical industry in Indonesia to provide quality drugs. To support the quality requirements, it's on the hand of the personnel who played a role in the pharmaceutical industry. One of these personnel is a pharmacist. Government Regulation no.51st in 2009 on Pharmaceutical Works mention that every pharmaceutical industries required to have a minimum of three Indonesian nationals Pharmacists who have full obligation in production, quality assurance, and quality control. Therefore, Faculty of Pharmacy, University of Indonesia coorporating with PT Taisho Pharmaceutical Indonesia Tbk toorganized Pharmaceutical Internship Program in 9 September - 30 October 2013. Specific Assignment titled "Critical Point in Dispensing, Mixing, Filling and Packaging Process of Tempra® Product" aims to determine critical points in production process that can affect the quality of the product."

"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."

"ABSTRAKPraktek Kerja Profesi Apoteker dilaksanakan di PT. Taisho PharmaceuticalIndonesia Tbk. Jalan Raya bogor KM 38. Kegiatan PKPA ini bertujuan agarmahasiswa profesi apoteker dapat melihat langsung aktivitas yang berlangsungdalam suatu industri farmasi, memperoleh pengetahuan dan wawasan tentangsegala aspek yang terkait di industri farmasi terutama dalam hal penerapan CPOBdi PT. Taisho Pharmaceutical Indonesia dan dapat memiliki pemahaman yangmendalam mengenai peran dan tugas apoteker di industri farmasi. Tugas khususyang diberikan berjudul Pembuatan Format Annual Product Quality Review(APQR)

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ABSTRACTPharmacists Professional Practice implemented in PT. Taiho PharmaceuticalIndonesia Tbk., Jalan Raya Bogor KM38. PKPA activity is intended that studentscan see the direct profession pharmacists activity that takes place in thepharmaceutical industry, gaining knowledge and insight into everything relatedaspects in the pharmaceutical industry, especially in terms of the implementationof GMP in PT. Taisho Pharmaceutical Indonesia Tbk. and may have a deepunderstanding of the role and duties of the pharmacist in the pharmaceuticalindustry. Special task given New Format of Annucal Product Quality Review (APQR)."

"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."

"Praktik kerja profesi apoteker di PT. Taisho Pharmaceutical bertujuan untuk mengetahui peran apoteker dalam industri farmasi. Di Industri farmasi apoteker memegang peran penting dalam proses produksi, pengendalian mutu dan pemastian mutu dari produk farmasi yang dihasilkan. Di dalam proses produksi, salah satu peran apoteker adalah menjamin proses produksi dijalankan sesuai dengan kaidah Cara Pembuatan Obat yang Baik. Oleh karena itu, proses produksi selalu didokumentasikan dalam batch record yang terdiri dari dokumen pengelolaan induk dan dokumen pengemasan induk. Dokumen pengemasan induk berisi informasi terkait proses pengemasan tiap produk spesifik yang disusun secara jelas untuk menghasilkan produk akhir yang aman, bermutu dan berkhasiat serta ekonomis. Dalam mencapai tujuan tersebut, PT. Taisho Pharmaceutical melakukan simplifikasi dokumen pengemasan induk yang mengacu pada konsep lean manufacturing. Selama program praktik kerja ini, telah berhasil dilakukan simplifikasi dokumen pengemasan induk dari produk theragran tablet, engran tablet, kenacort tablet, myco-z cream, kenalog in oral base, stugeron tablet, Imodium tablet, daktarin cream 5 gram, daktarin cream 10 gram, dan nizoral ss 1%.

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Pharmacist internship in PT. Taisho Pharmaceutical aims to determine the role of pharmacists in the pharmaceutical industry. Pharmacist in pharmaceutical industry plays an important role in the production process, quality control and quality assurance of pharmaceutical products produced. In the production process, one of the pharmacist's role is to ensure that the production process is executed in accordance with the principles of Good Manufacturing Practice. Therefore, the production process is always documented in the batch record consisting of manufacturing instruction and packaging instruction. Packaging instruction contains information about packaging process for each specific product are clearly arranged to produce a final product that is safe, quality, efficacious and economical. In achieving these objectives, PT. Taisho Pharmaceutical did simplification for the packaging instruction with the concept of lean manufacturing. During internship, successfully did simplification of packaging instruction of theragran tablets, engran tablets, kenacort tablets, Myco-z cream, kenalog in oral base, stugeron tablets, Imodium tablets, daktarin cream 5 grams, 10 grams of daktarin cream, and Nizoral SS 1%."

"ABSTRAKKesehatan merupakan hak asasi manusia dan salah satu unsur kesejahteraan yang harus diwujudkan sesuai dengan cita-cita bangsa Indonesia sebagaimana dimaksud dalam Pancasila dan Undang-Undang Dasar Negera Republik Indonesia Tahun 1945. Apoteker memiliki peran yang penting dalam industri farmasi agar obat yang dihasilkan bermutu, aman dan berkhasiat. Penerapan CPOB di PT. Taisho Pharmaceutical Tbk. mengikuti aspek-aspek yang tertera dalam CPOB yaitu manajemen mutu, personalia, bangunan dan fasilitas, peralatan, sanitasi dan higiene, produksi, pengawasan mutu, inspeksi diri dan audit mutu, penanganan keluhan terhadap produk, penarikan kembali obat dan produk kembalian, dokumentasi, pembuatan dan analisis berdasarkan kontrak, serta kualifikasi dan validasi

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ABSTRACTHealth is a human right and one of the elements of welfare that must be realized in accordance with the ideals of the Indonesian nation as referred to in Pancasila and the Constitution of the Republic of Indonesia in Year 1945. Pharmacists have an important role in the pharmaceutical industry for the resulting drug quality, safe and efficacious. Implementation of CPOB at PT. Taisho Pharmaceutical Tbk. followed the aspects contained in the CPOB namely quality management, personnel, buildings and facilities, equipment, sanitation and hygiene, production, quality control, self inspection and quality audit, complaints handling products, drug recalls and return products, documentation, and contractual analysis, as well as qualification and validation."

"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."