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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."

"Industri farmasi merupakan badan usaha yang memiliki izin untuk melakukan kegiatan pembuatan obat atau bahan obat. Industri harus selalu memenuhi persyaratan Cara Pembuatan Obat yang Baik untuk menjamin bahwa obat yang dihasilkannya bermutu, aman, dan efektif. Kualitas obat yang ditawarkan industri kepada pelanggan haruslah kualitas yang baik dengan harga yang terjangkau dan pelayanan yang baik. Di sisi lain industri memerlukan laba untuk dapat melanjutkan aktivitas bisnis perusahaannya dan bertahan di dalam persaingan. Hal tersebut dapat diperoleh dengan melakukan perbaikan berkelanjutan continuous improvement yang memanfaatkan tools Operational Excellence. Pemanfaatan tools Operational Excellence dipilih sebagai topik tugas khusus. Tugas khusus dilakukan terhadap produk yang paling diminati di pasaran yaitu Tablet Flu Berlapis dan Tablet Multivitamin Salut Gula.

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Pharmaceutical industries is a business entity that has permission to perform activities of producing medicines or medicinal materials. The industry has to fulfill the requirements of Good Manufacturing Practice to ensure that the medicines they produce are high quality, safety, and effective. The quality of medicines that industry offers to customers must be good quality with affordable price and good services. On the other hand, industry needs profits to continue its business activities and survive in the competition. This can be achieved by continuous improvement using Operational Excellence tools. The implementation of Operational Excellence tools was chosen as the topic of specific task. Specific task was performed to the products that highly market demand, such as Layered Flu Tablet and Sugar coated Multivitamin Tablet."

"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."

"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. "

"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. "

"Seorang apoteker memegang peranan penting di industri farmasi. Apoteker harus memenuhi standar kompetensi sebagai persyaratan untuk memasuki dunia kerja dan menjalani praktik profesi. Standar kompetensi apoteker Indonesia terdiri dari sepuluh (10) standar kompetensi 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 Medifarma Laboratories, periode bulan Maret-April tahun 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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A pharmacist plays an important role in the pharmaceutical industries. Pharmacists must meet competency standards as a requirement for entering the workforce and undergoing professional practice. Indonesian pharmacist competency standards consist of ten (10) competency standards as abilities expected by pharmacists when graduating and entering professional work practices. As a preparation and experience of prospective pharmacists to be able to understand the role of pharmacists and improve competence, the Pharmacist Professional Work Practice is carried out at PT. Medifarma Laboratories for the period March-April 2019. During PKPA it is expected that pharmacist candidates can broaden their horizons , understanding, and experience to do pharmaceutical work in professional workplaces"