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"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. "

"ABSTRAKPraktik Kerja Profesi Apoteker PKPA dilaksanakan di PT Medifarma Laboratories pada 18 Juli 2016 hingga 9 September 2016. Tujuan dilaksanakannya Praktik Kerja Profesi di Industri Farmasi PT Medifarma Laboratories agar calon Apoteker mampu 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 GMP/CPOB di Industri Farmasi serta memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Kegiatan yang dilakukan selama praktik kerja profesi di PT Medifarma Laboratories meliputi pemberian materi basic GMP, safety induction, profil perusahaan dan struktur organisasi perusahaan, plan tour, induction tiap-tiap departemen di PT Medifarma Laboratories, penempatan di Departemen Pengawasan Mutu, pengerjaan tugas khusus berupa perbaikan berkelanjutan, dan presentasi akhir. Kata Kunci : Industri Farmasi, Medifarma Laboratories, Praktik Kerja Profesixiii 78 : 37 LampiranReferensi : 11 2007 - 2016

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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 Apothecary student understand roles and responsibilities of Pharmacist in Pharmaceutical Industry to get insights, knowledges, skills, and practical experience to perform pharmaceutical practice understand to apply of GMP in Pharmaceutical Industry, and to gets an overview about pharmaceutical practice issues in Pharmaceutical Industry. Activity at PT Medifarma Laboratories were basic GMP materials, safety induction, profile of the company and organization structure, plan tour, induction at department at PT Medifarma Laboratories, placement at Quality Control Department, continuous improvement for special assignment and final presentation. Keywords Pharmaceutical Industry, Medifarma Laboratories, Profession Internshipxiii 78 37 AppendicesBibliography 11 2007 2016 "

"ABSTRAKIndustri farmasi merupakan salah satu sarana tempat dilakukan pekerjaan kefarmasian. Praktik kerja profesi yang dilaksanakan di PT Medifarma Laboratories ini, bertujuan agar mahasiswa mendapatkan pengalaman nyata dalam melakukan pekerjaan kefarmasian di industri farmasi. Industri farmasi adalah badan usaha yang memiliki izin untuk melakukan kegiatan pembuatan obat atau bahan obat. Dalam pembuatan obat, industri farmasi harus memenuhi ketentuan Cara Pembuatan Obat yang Baik CPOB agar obat yang dihasilkan aman, berkhasiat dan bermutu. Seluruh aspek CPOB telah diterapkan oleh PT Medifarma Laboratories. Selain itu, PT Medifarma Laboratories juga menerapkan ketentuan GMP dari PIC/s sebagai jaminan tambahan untk keperluan ekspor produk. Seluruh proses produksi dan aspek terkait telah dikendalikan, dan setiap tahapnya telah terdokumentasikan. Salah satu upaya pengendalian dalam proses produksi adalah validasi proses yang menjadi tugas khusus yang diberikan kepada mahasiswa. Validasi proses merupakan usaha untuk membangun bukti terdokumentasi bahwa suatu proses produksi akan senantiasa menghasilkan produk yang memenuhi kriteria yang ditentukan. Validasi ini termasuk dalam validasi konkuren, dilakukan terhadap pada tiga bets tablet suplemen XYZ berturut-turut, dimana tiap bets berukuran 100.000 tablet. Validasi proses telah dilakukan mulai dari tahap wet compounding, dry mixing, compression dan coating. Validasi terhadap proses blistering tablet suplemen XYZ juga telah dilakukan. Dari hasil validasi, disimpulkan bahwa proses produksi tiga bets tablet suplemen XYZ telah tervalidasi.

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ABSTRACTThe pharmaceutical industry is one of the places to do the pharmaceutical works. The internship that held at PT Medifarma Laboratories, intended to make students get the real experience in performing the pharmaceutical works in the pharmaceutical industry. The pharmaceutical industry is an entity that has a license to conduct the manufacture of drugs or drug ingredients. In the manufacture of drugs, the pharmaceutical industry must comply Good Manufacturing Practice GMP so that the resulting drug meet the criteria of safe, efficacy and quality. All aspects of GMP has been applied by PT Medifarma Laboratories. In addition, PT Medifarma Laboratories also applying the GMP provisions of PIC s as an additional guarantee for export products. The whole process of production and its related aspects are controlled, and every stage is documented. One of the actions in order to control the production process is validation process that became task given to the student. The validation process is establishing documented evidence to determine that process consistently produce a product meet its predetermined specifications and quality characteristics. Validation that had been done is classified as concurrent validation, and were carried out on three batches of Tablet Supplements XYZ, where the size of each batch were 100.000 tablets. Validation process were started from wet compounding, dry mixing, compression, and coating. Validation of the blistering process Tablets Supplement XYZ had also been performed. The results showed that the production process of three batches of Tablet Supplements XYZ had been validated."

"ABSTRAKPraktek Kerja Profesi Apoteker di PT Actavis Indonesia bertujuan agar calon apoteker memahami peranan, tugas, dan tanggung jawab apoteker di industri farmasi, memiliki wawasan, pengetahuan, keterampilan dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi, serta dapat memahami penerapan Cara Pembuatan Obat yang Baik di industi farmasi. Praktek kerja ini juga bertujuan untuk mengetahui gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang diberikan berjudul Validasi Proses Pembuatan Tablet Freegas di PT Actavis Indonesia. Tujuan penyusunan tugas khusus ini adalah untuk memahami pelaksanaan protokol validasi proses pembuatan Tablet Freegas di PT Actavis Indonesia.

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ABSTRACTInternship at PT Actavis Indonesia was intended to make apothecary student understand the role, duties and responsibilities of pharmacists in the pharmaceutical industry, have the insight, knowledge, skills and practical experience to do the work of pharmacy in the pharmaceutical industry, as well as to understand the application of good manufacturing practices of medicines in industry. This practice also aims to know the real picture about the problems of pharmaceutical works in the pharmaceutical industry. Special assignment given entitled Process Validation of Freegas Tablet at PT Actavis Indonesia. The purpose of the special task is to understand the implementation of process validation protocols of Freegas Tablet at PT Actavis Indonesia."

"ABSTRAKIndustri farmasi adalah badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat. Industri farmasi wajib memenuhi persyaratan Cara Pembuatan Obat yang Baik CPOB . Praktek Kerja Profesi PKP di PT. Medifarma Laboratories dilakukan pada tanggal 1 Februari ndash; 31 Maret 2017. Tujuan pelaksanaan PKP untuk memperoleh gambaran dan pengalaman mengenai peran profesi apoteker di industri farmasi, khususnya dalam bidang pemastian mutu. Kegiatan yang dilakukan selama PKP antara lain pengenalan secara umum mengenai PT. Medifarma Laboratories; induksi ke departemen yang berkaitan dengan pekerjaan kefarmasian yaitu Quality Assurance QA , Quality Control QC , Engineering, Production, Health Safety Environment HSE , Manufacturing Technology Unit MTU , logistic, dan membantu pekerjaan di Departemen QA seperti memeriksa dokumen untuk pelolosan produk jadi, dan membuat dokumen registrasi salah satu produk Medifarma. Medifarma Laboratories merupakan salah satu industri farmasi yang telah menerapkan pedoman CPOB dalam setiap kegiatan yang dilakukan, baik dalam proses produksi, pengawasan dan pemastian mutu, serta kegiatan lain yang terkait.

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ABSTRACTPharmaceutical industry is a corporation that has a license from Minister of Health to manufacturing of drugs or drug materials. Pharmaceutical industry is obliged to comply with the requirements of Good Manufacturing Practice for Pharmaceuticals GMP . Profession internship at PT. Medifarma Laboratories held on February 1st to March 31st 2017. The aim of profession internship to obtain an overview and experience of professional role of pharmacists in pharmaceutical industry, particularly in a quality assurance. Activities conducted during profession internship among other general introduction about PT. Medifarma Laboratories induction into department which related pharmacy that are Quality Assurance QA , Quality Control QC , Engineering, Production, Health Safety Environment HSE , Manufacturing Technology Unit MTU , logistic and help the task at QA Department such as review document for finish good release and making dossier for registration one of product in PT.Medifarma Laboratories. PT. Medifarma Laboratories is the one of pharmaceutical industry which has implemented the GMP guidelines in each of activities, both in production process, control and quality assurance, and other related activities. "

"ABSTRAKPraktik kerja profesi di PT. Medifarma Laboratories Periode Bulan Agustus-September 2017 bertujuan untuk mengetahui tugas dan tanggung jawab apoteker di industri farmasi dan memahami penerapan Cara Pembuatan Obat yang Baik CPOB di Industi Farmasi. Selain itu calon apoteker juga dapat memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang diberikan yaitu berjudul ldquo;Value Stream Mapping Produk Jadi rdquo;. Tujuan dari tugas khusus ini adalah mengidentifikasi waste dan akar penyebab waktu tunggu proses pengiriman produk jadi dan penumpukan produk jadi di secondary packaging, staging area dan warehouse, serta mengusulkan ide continous improvement untuk mengurangi waktu tunggu dan penumpukan produk jadi di secondary packaging, staging area, dan warehouse.

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ABSTRACTInternship at PT. Medifarma Laboratories month period August-September 2017 aims to understand the duties and responsibilities of pharmacists in the pharmaceutical industry and the understanding of the application of good manufacturing practice GMP in the pharmaceutical industry. In addition, the pharmacist candidate can also have the insight, knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry. The special assignment given is ldquo;Value Stream Mapping of Finished Goods rdquo;. The purpose of this special assignment is to identify waste and root cause of lead time of finished product delivery and accumulation of finished product in secondary packaging, staging area and warehouse, and propose continous improvement idea to reduce lead time and accumulation of finished product in secondary packaging, staging area and warehouse "

"ABSTRAKPraktek Kerja Profesi (PKP) di Industri PT. Medifarma Laboratories bertujuan agar calon apoteker memiliki wawasan, pengetahuan, keterampilan, dan pengalaman dalam melakukan pekerjaan kefarmasian, kemudian agar dapat memahami penerapan Cara Pembuatan Obat yang Baik (CPOB) di industri dan gambaran nyata permasalahan yang dapat terjadi. PKP dilakukan selama 2 bulan dengan mempelajari sebagian departemen industri dan secara khusus di departemen Quality Control untuk melakukan tugas khusus. Tujuan dari pelaksanaan tugas khusus yaitu meningkatkan efisiensi membran filter padapenyaringan fase gerak untuk analisa di Kromatografi Cair Kinerja Tinggi (KCKT) dan menilai parameter yang berkaitan dengan penggunaan membran filter berulang. Peran apoteker dalam industri farmasi yaitu berada di posisi kunci meliputi produksi, Quality Control dan Quality Assurance. Penerapan CPOB diperoleh mahasiswa dengan mengikuti training basic GMP dan penjelasan setiap departemen.

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ABSTRACTProfession internship at PT. Medifarma Laboratories company aims pharmacistcandidate has knowledge, skill, and experience for doing pharmacist jobs, then to know the implementation Good Manufacturing Product (GMP) in pharmaceuticals industry and to face the real working world the problem thatcould be held. Profession internship was held during two months which studied a lot of section on the company and Quality Control specifically. Given specialassignment in QC department which is about membrane filter. The aims toincrease the efficiency membrane filter on the mobile phase filtration foranalyzing in High Performance Liquid Chromatography (HPLC) and to give avalue on the parameter which is related with the usage membrane filter usage. The role of pharmacist in pharmaceutical industry is key position on production, Quality Control and Quality Assurance department. The implementation of GMP which is get with joining GMP training basic and the explanation every department."

"Praktek Kerja Profesi Apoteker di PT. Fonko International Pharmaceuticals bertujuan untuk memahami peran serta tanggung jawab Apoteker di industry farmasi, peran serta tanggung jawab transfer proses dan produk obat di Departemen Technical Service PT. Fonko International Pharmaceuticals, serta memahami proses pengembangan produk obat di industry farmasi sesuai dengan aturan pemerintah Indonesia. Tugas Khusus yang diberikan berjudul Pembuatan Dokumen Working Instruction Panduan Pelaksanaan Validasi Proses PT. Fonko International Pharmaceuticals. Tujuan penyusunan tugas khusus ini adalah memahami cara menyusun Working Instruction Panduan Pelaksanaan Validasi Proses dan memahamiaspek-aspek penting yang perlu diperhatikan dalam penyusunan Working Instruction Panduan Pelaksanaan Validasi Proses.

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Internship at PT. Fonko International Pharmaceuticals on July September 2016 has aims to understand the role and responsibilities of pharmacist in the pharmaceutical industry, roles and responsibilities for the product and process transfer of medicinal products in the Department of Technical Service, PT. Fonko International Pharmaceuticals, 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 Creating Working Instruction Document of Process Validation Implementation Guide at PT. Fonko International Pharmaceuticals rdquo . The purpose of the main task is to understand how to create Working Instruction Document of Process Validation Implementation Guide and understand the important aspects that need to be considered to create Working Instruction Document of Process Validation Implementation Guide."

"ABSTRAK Industri Farmasi merupakan suatu badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat yang meliputi pengadaan bahan awal dan bahan pengemas, produksi, pengemasan, pengawasan mutu, dan pemastian mutu sampai diperolehnya obat untuk didistribusikan. Praktek Kerja Profesi Apoteker di PT. Medifarma Laboratories bertujuan agar mahasiswa PKPA mampu memahami tugas dan tanggung jawab di Industri Farmasi, memahami penerapan CPOB di Industri Farmasi, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Selain itu, mahasiswa PKPA juga diberikan tugas khusus yang berjudul Peningkatan Yield pada Tahap Pencetakan Tablet Multilayer Fenilpropanolamin Menggunakan Metode Statistical Process Control di Departemen Produksi. Tugas khusus bertujuan agar mahasiswa PKPA mampu memahami dan mengaplikasikan tools Statistical Process Control (SPC) sebagai salah satu tools dari Operational Excellence pada proses produksi di industri farmasi, meningkatkan yield tablet multilayer Fenilpropanolamin di Departemen Produksi menggunakan metode Statistical Process Control (SPC), serta mengetahui proses apa saja yang harus dilakukan pada saat SPC untuk meningkatkan yield dari proses pencetakan tablet.

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ABSTRACTPharmaceutical industry is a business entity that has a licence from the Minister of Health to conduct the manufacture of drugs or excipients which include the procurement of starting materials and packaging materials, production, packaging, quality control, quality assurance, until the distribution of drugs. The internship program was aimed to make students understand the duties and responsibilities, to understand the implementation of GMP, and also the challenges in pharmaceutical industry. In addition, students are also given a special assignment titled Peningkatan Yield pada Tahap Pencetakan Tablet Multilayer Fenilpropanolamin Menggunakan Metode Statistical Process Control di Departemen Produksi. The special assignment was aimed to make students be able to understand the implementation of Statistical Process Control (SPC) as one of Operational Excellence tools in Production Department, to increase the yields of Phenylpropanolamine tablet using Statistical Process Control (SPC), and also to know the process of SPC to increase the yield of Phenylpropanolamine tablet. "