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"Praktek Kerja Profesi Apoteker di PT Novell Pharmaceutical Laboratories Jalan Pos Pengumben Raya No.8 Jakarta Barat bertujuan untuk memahami peran serta tanggung jawab apoteker di industri farmasi, peran serta tanggung jawab pengembangan produk obat di Departemen Business Development PT Novell, serta memahami proses pengembangan produk obat di industri farmasi sesuai dengan aturan pemerintah Indonesia. Tugas Khusus yang diberikan berjudul Penelusuran dan Kajian Paten Senyawa Desloratadin. Tujuan penyusunan tugas khusus ini adalah untuk memahami prosedur penelusuran dan pengkajian paten senyawa Desloratadin berdasarkan Standard Operating Procedure di PT Novell serta mengetahui manfaat penelusuran paten sebelum dilakukan pengembangan produk.

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Pharmacists Profession Job Training at PT Novell Pharmaceutical Laboratories Jalan Raya Pos Pengumben 8, West Jakarta has aims to understand the role and responsibilities of pharmacists in the pharmaceutical industry, roles and responsibilities for the development of medicinal products in the Department of Business Development, PT. Novell, as well as understand the process of development of medicinal products in the pharmaceutical industry in accordance with the rules of the Indonesian government. Special task given entitled ldquo Finding Searching and Assessment of Patent Study of Desloratadine rdquo . The purpose of the main task is to understand the search and assessment procedures of Desloratadine patents compounds based on Standard Operating Procedure at PT. Novell and knowing the benefits of patent searching prior to product development. "

"ABSTRAKPraktek Kerja Profesi Apoteker di PT Novell Pharmaceutical Laboratories dilaksanakan pada bulan Juli sampai September tahun 2016. Pelaksanaan praktek kerja profesi ini bertujuan untuk memahami peran serta tanggung jawab Apoteker di industri farmasi dan dalam proses pengembangan produk, khususnya di Departemen Business Development PT. Novell Pharmaceutical Laboratories. Proses pengembangan produk obat dan regulasi obat di industri farmasi harus sesuai dengan aturan pemerintah Indonesia. Tugas khusus diberikan berjudul penyusunan dokumen registrasi nonklinik dan klinik larutan injeksi magnesium sulfat sesuai kriteria dan tatalaksana registrasi obat oleh Badan Pengawas Obat dan Makanan BPOM . Tujuan penyusunan tugas khusus adalah untuk mengetahui tujuan dilakukan penyusunan dokumen klinik dan nonklinik serta memahami prosedur penyusunan dokumen klinik dan nonklinik injeksi magnesium sulfat sesuai dengan Kriteria dan Tatalaksana Registrasi Obat oleh BPOM.

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ABSTRACTPharmacists profession internship at PT Novell Pharmaceutical Laboratories was held on July to September 2016. Implementation of this internship aimed to understand the role and responsibilities of pharmacists in the pharmaceutical industry and the development of medicinal products, especially in Department of Business Development, PT. Novell Pharmaceutical Laboratories. The process of development of medicinal products in the pharmaceutical industry must be in accordance with the rules of the Indonesian government. Special task given to support the internship activities was entitled Preparation of Non Clinical and Clinical Registration Documents of Magnesium Sulfate Injection according to the drug registration criteria and procedure by drug and food supervisory agency BPOM . The purpose of the special task are to understand the purpose of composing clinic and nonclinical documents, as well as understand the procedure of clinical and nonclinical documents arrangement of magnesium sulfate injection in accordance with BPOM drug registration criteria and procedure."

"Apoteker memegang peranan penting di industri farmasi, apotek, dan pemerintahan. Seorang apoteker harus memenuhi standar kompetensi sebagai persyaratan untuk memasuki dunia kerja dan menjalankan praktik profesi. Standar kompetensi apoteker Indonesia terdiri dari sepuluh standar kompentensi sebagai kemampuan yang diharapkan oleh apoteker saat lulus dan masuk ke tempat praktik kerja profesi. Sebagai bekal dan pengalaman calon apoteker untuk dapat memahami peran apoteker dan meningkatkan kompetensi, maka dilaksanakan Praktik Kerja Profesi Apoteker di PT. Novell Pharmaceutical Laboratories, Apotek Hidup Baru, dan Suku Dinas Kesehatan Kota Administrasi Jakarta Timur selama periode bulan Januari-April 2019. Selama PKPA, diharapkan calon apoteker dapat memperluas wawasan, pemahaman, dan pengalaman untuk melakukan pekerjaan kefarmasian di tempat praktik kerja profesi.

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Pharmacists have an important role as one of the healthcare professional. Pharmacists must comply with the competency standards before get into the professional practices. Therefore, in order to get experiences working as a healthcare professional, the Pharmacists Internship Program that called as Praktik Kerja Profesi Apoteker (PKPA) have been implemented. The prospective pharmacists get to do the internship at several places, such as PT. Novell Pharmaceutical Laboratories, Apotek Hidup Baru, and East Jakarta Administration City Health Office period January-April 2019. The prospective pharmacists are expected to get more knowledge and experiences to do the pharmaceutical practices in various places during the PKPA. "

"Industri farmasi memiliki peranan yang penting dalam ketersediaan obat untuk melakukan kegiatan pembuatan obat atau bahan obat. Mutu suatu obat tidak dapat ditentukan berdasarkan pemeriksaan produk akhir saja, melainkan selama keseluruhan proses pembuatan produk obat. Apoteker merupakan salah satu tenaga inti di suatu industri farmasi. Calon apoteker perlu mendapatkan bekal pengetahuan dan pengalaman yang memadai untuk memenuhi standar kompetensi yang diperlukan. Salah satu cara untuk mencapainya adalah dengan kegiatan Praktek Kerja Profesi Apoteker di industri farmasi yaitu PT. Novell Pharmaceutical Laboratories. Kegiatan PKPA ini bertujuan agar calon apoteker dapat mengetahui dan memahami peran serta tanggung jawab apoteker di industri farmasi serta memahami proses pengembangan produk obat dan regulasi obat di industri farmasi sesuai dengan aturan pemerintah Indonesia. Praktek kerja profesi ini dilaksanakan mulai dari tanggal 3 Januari ndash; 28 Februari 2017. Berdasarkan PKPA yang telah dilakukan, Apoteker di PT. Novell Pharmaceutical Laboratories dapat berperan di beberapa departemen yang setiap departemennya bekerja sama sesuai dengan tugas dan fungsinya masing-masing. PT. Novell Pharmaceutical Laboratories melakukan pengembangan produk sesuai dengan ketentuan yang tercantum dalam CPOB dan mendaftarkannya ke BPOM, sehingga diperoleh produk obat yang terjamin mutu, khasiat, dan keamanannya.

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The pharmaceutical industry has an important role in the availability of medicines for the manufacture of drugs or medicinal materials. The quality of a drug can not be determined on the basis of examination of the final product alone, but during the entire process of producing the drug product. Pharmacists are one of the core personnel in a pharmaceutical industry. Prospective pharmacists need to obtain sufficient knowledge and experience to meet the required competency standards. One way to achieve this is with the activities of internship in the pharmaceutical industry, PT. Novell Pharmaceutical Laboratories. This activity is aimed to prospective pharmacist to know and understand the role and responsibility of pharmacist in the pharmaceutical industry and understand the process of developing drug products and drug regulation in the pharmaceutical industry in accordance with Indonesian government regulations. This internship is carried out from January 3rd to February 28th, 2017. Based on internship that has been done, the Apothecary at PT. Novell Pharmaceutical Laboratories can play a role in several departments where each department works in accordance with their respective tasks and functions. PT. Novell Pharmaceutical Laboratories undertakes product development in accordance with the provisions contained in the CPOB and register it to BPOM, so as to obtain a product of quality assured, efficacy, and safety."

"Praktek Kerja Profesi (PKP) bidang industri dilaksanakan di Departemen Product Development PT Novell Pharmaceutical Laboratories. Kegiatan ini berlangsung selama delapan minggu, mulai dari tanggal 18 Januari 2016 sampai dengan 11 Maret 2016. Kegiatan PKP ini bertujuan agar calon apoteker 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 di industri farmasi; dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Apoteker di PT Novell Pharmaceutical Laboratories bertanggung jawab dalam proses pembuatan produk, mulai dari perencanaan produk, pengembangan produk, pengembangan metode analisis, formulasi, validasi, produksi, pengawasan mutu, pemastian mutu, pendaftaran obat jadi, sampai produk dipasarkan. PT Novell Pharmaceutical Laboratories telah memenuhi semua aspek CPOB yang diterjemahkan ke dalam bentuk Standard Operation Procedure (SOP) dan Standard Operation Instruction (SOI) pada masing-masing pelaksanaan kegiatan. Dari pelaksanaan PKP di PT Novell Pharmaceutical Laboratories, mahasiswa menjadi lebih memperkaya wawasan, pengetahuan, keterampilan, dan pengalaman praktis dalam melakukan pekerjaan kefarmasian di industri farmasi secara umum dan di bidang analytical development secara khusus.

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Internship at pharmaceutical industry was held in the Department of Product Development PT Novell Pharmaceutical Laboratories. This activity was held for eight weeks, from January 18th, 2016, until March 11th, 2016. This internship was aimed to make apothecary student understand the roles, duties, and responsibilities of pharmacists in the pharmaceutical industry; have the insight, knowledge, skills, and practical experience to work in the pharmaceutical industry; understand the implementation of Good Manufacturing Practices (GMP) in the pharmaceutical industry; and know the issues in pharmaceutical practice in the pharmaceutical industry. Pharmacists in PT Novell Pharmaceutical Laboratories were responsible in the manufacturing process of products, starting from product planning, product development, analytical method development, formulation, validation, production, quality control, quality assurance, registration, until the product is marketed. PT Novell Pharmaceutical Laboratories has complied with all aspects of GMP, that is translated into the Standard Operation Procedure (SOP) and Standard Operation Instruction (SOI) in each of the activities. From internship at PT Novell Pharmaceutical Laboratories, apothecary students become more enriching their knowledge, skills, and practical experience in doing pharmaceutical jobs in the pharmaceutical industry (in general) and in the field of analytical development (in particular)."

"Praktek Kerja Profesi Apoteker di Apotek Kimia Farma No.254 Pos Pengumben dilaksanakan selama 4 minggu dari 1-31 Mei 2016. Praktek Kerja Profesi ini bertujuan agar mahasiswa memahami tugas dan tanggung jawab apoteker dalam pengelolaan apotek, serta melakukan praktek pelayanan kefarmasian sesuai dengan ketentuan perundang-undangan dan etika yang berlaku. Secara keseluruhan kegiatan pelayanan kefarmasian di Apotek Kimia Farma No.256 yang meliputi Pengelolaan Sediaan Farmasi, Alat Kesehatan, dan Bahan Medis Habis Pakai telah sesuai dengan Permenkes No. 35 Tahun 2015 tentang Standar Pelayanan Kefarmasian di Apotek tahun 2014. Tetapi untuk kegiatan Pelayanan Farmasi Klinis masih perlu ditingkatkan. Tujuan khusus dalam Praktek Kerja Profesi Apoteker di Kimia Farma No.254 Pos Pengumben agar mahasiswa dapat menganalisis kerasionalan resep dari pasien Rheumatoid Arthritis atau Rematik.

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Pharmacist Professional Practice in Kimia Farma 254 Pos Pengumben was held 4 weeks from May 1st-31st, 2016. The Profession practice aims for students to be able to understand the duties and responsibilities of pharmacists in Pharmacy (Apotek) management, and to practice pharmacy services in accordance with the provisions of law and pharmaceutical ethics. Overall, the activity in the pharmaceutical service Kimia Farma 256 which includes the Management of Pharmaceutical Products, Medical Devices, Medical Materials and Consumables accordance with Permenkes No. 35, 2015 on Standards of Pharmaceutical Services in Pharmacy , 2014. But for Clinical Pharmacy Services activities need to be improved. Special assigment given intended students to analyze the rationality of recipes from patients with rheumatoid arthritis."

"ABSTRAKPraktek Kerja Profesi Apoteker dilaksanakan di PT. Novell Pharmaceutical Laboratories Jalan Wanaherang No 35, Gunung Putri, Bogor. Praktek Kerja Profesi Apoteker bertujuan agar mahasiswa profesi apoteker memahami peran, tugas, serta tanggung jawab apoteker di industri farmasi; memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri; serta memahami penerapan CPOB di industri farmasi. Tugas khusus yang diberikan berjudul Pengembangan Metode Analisa Zelavel Infus 2 mg/ml Menggunakan Metode Spektrofotometri UV-VIS Sebagai Alternatif Metode Kromatografi Cair Kinerja Tinggi. Tugas khusus ini bertujuan untuk memperoleh metode alternatif penetapan kadar Zelavel Infus 2 mg/ml serta memahami prosedur penyusunan dokumen Standard Operational Instruction (SOI) pemeriksaan produk jadi, produk antara, dan produk ruahan.

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ABSTRACTApothecary Internship conducted at PT. Novell Pharmaceutical Laboratories Jalan Wanaherang No 35, Gunung Putri, Bogor. Apothecary internship aimed to obtain practical experience and understanding about the duties and responsibilities of pharmacist in industry; to obtain knowledge, skills, and practical experience; to perform the pharmacy practice in industry; and to understand the implementation of Good Manufacturing Practice in pharmaceutical industry. Special assignment given, entitled Analytical Methods Development of Zelavel Infusion 2 mg/ml using UV-Vis Spectrophotometry as an Alternative Method of High Performance Liquid Chromatography. This particular task is to obtain alternative methods assay of Zelavel Infusion 2 mg/ml and understand the procedure of preparing documents Standard Operational Instruction (SOI) inspection of finished products, intermediate products, and bulk products."

"ABSTRAKPraktek Kerja Profesi Apoteker PKPA dilaksanakan di PT. Medifarma Laboratories pada 18 Juli 2016 hingga 9 September 2016. Tujuan dilaksanakannya Praktek Kerja Profesi di Industri Farmasi 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 CPOB di Industri Farmasi; dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Kegiatan yang dilakukan selama praktek kerja profesi di PT. Medifarma Laboratories meliputi pemberian materi basic GMP, safety induction, profil perusahaan dan struktur organisasi perusahaan, plan tour, induction masing-masing departemen di PT. Medifarma Laboratories, penempatan di Departemen Engineering, pengerjaan tugas khusus berupa perbaikan berkelanjutan, dan presentasi akhir.

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ABSTRACTInternship at PT. Medifarma Laboratories was started on July, 18th 2016 to September , 09th 2016. This internship was intended to make Apotechary student understand roles and responsibilities of apotechary in Pharmaceutical Industry to get insights, knowledges, skills, and practical experience to perform pharmaceutical practice understand to apply CPOB in Pharmaceutical Industry and to gets an overview about pharmaceutical practice issues in Pharmaceutical Industry. Activities at PT. Medifarma Laboratiries were basic GMP materials, safety induction, profile of the company and organization structure, plan tour, induction at each of departement at PT. Medifarma Laboratories, placement at Engineering Departement, continous improvement for special assigment and final presentation. "

"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. "