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"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."

"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 Apoteker di PT Medifarma Laboratories bertujuan agar mahasiswa profesi apoteker mengetahui dan memahami tugas, peran, dan tanggung jawab apoteker di suatu industri farmasi. Selain itu, kegiatan Praktik Kerja Profesi juga memfasilitasi mahasiswa dalam memahami gambaran nyata permasalahan kefarmasian di industri farmasi, khususnya pada bagian production planning and invertory control PPIC . Tugas khusus yang diberikan berjudul Pemetaan Mesin dan Kapasitas Mesin. Tujuan dari tugas khusus ini adalah untuk mengetahui kesesuain data antara perhitungan kapasitas mesin dengan sistem otomatis yang dibandingkan dengan perhitungan kapasitas mesin secara manual.

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ABSTRACTInternship at PT Medifarma Laboratories aims to make the pharmacist 39 s professional students know and understand the duties, roles and responsibilities of the pharmacist in a pharmaceutical industry. In addition, internship also facilitates students to understand the real picture of pharmaceutical problems in the pharmaceutical industry, especially in the production planning and inventory control PPIC section. Specific assignment given is entitled Machine Matriks and Machine Capacity. The purpose of this particular assignment is to ensure and compare the data of machine capacity between automatic system with manual system. "

"Praktik Kerja Profesi di PT. Medifarma Laboratories Periode 1 Februari ndash; 31 Maret Tahun 2017 bertujuan untuk mengerti peranan, tugas dan tanggung jawab apoteker di industri farmasi, memiliki wawasan, pengetahuan dan keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi, memahami penerapan CPOB, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang diberikan berjudul Analisis Uji Batas Timbal pada Bahan Baku Eksipien Pewarna yang bertujuan untuk mendapatkan prosedur analisis timbal pada bahan baku eksipien pewarna yang valid.

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Internship at PT. Medifarma Laboratories Period 1 February ndash 31 March Year 2017 aims to know and understand pharmacist work and responsibility at Pharmacy Industry, have competence, knowledge, skill, and experience to handle pharmacy work, understand implementation of GMP, and have real illustration about pharmacy work matter at Pharmacy Industry. The internship given a special assignment about Lead Limit Test Analysis for Raw Materials of Color Excipient with aim to get lead analytical valid procedure for raw materials of color excipient. "

"ABSTRAKPraktek Kerja Profesi (PKP) di industri farmasi dilaksanakan di DepartemenQuality Control (QC) PT Medifarma Laboratories. Kegiatan ini berlangsungselama 2 bulan dari tanggal 1 Juli sampai dengan tanggal 31 Agustus 2015. PKP diindustri bertujuan agar mahasiswa apoteker mengerti peranan, tugas, dan tanggungjawab Apoteker di Industri Farmasi; memiliki wawasan, pengetahuan,keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian diIndustri Farmasi; memahami penerapan CPOB di Industri Farmasi; memilikigambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi.Berdasarkan kegiatan PKP yang dilakukan, dapat disimpulkan bahwa peranapoteker penting untuk menghasilkan obat-obatan yang aman, bermutu, danberkhasiat. Apoteker di Departemen QC bertanggung jawab untuk melakukanpengawasan mutu terhadap produk yang diproduski dan memastikan bahwapengujian yang diperlukan dan relevan telah dilakukan dan bahwa bahan yangbelum diluluskan tidak digunakan serta produk yang belum diluluskan tidak dijualatau dipasok sebelum mutunya dinilai dan dinyatakan memenuhi syarat. Mahasiswaapoteker telah berhasil memperoleh gambaran umum dari pelaksanaan pekerjaankefarmasian di PT Medifarma., khususnya di bidang QC yaitu melakukan analisisterhadap bahan awal, produk jadi, inspeksi bahan awal. Dalam melakukan tugasnyadi QC juga mahasiswa apoteker membuat Spreadsheet dan cara memvalidasinyauntuk mendukung analisis dan inspeksi bahan awal. Adanya PKP di PT MedifarmaLaboratories yang telah melaksanakan CPOB dengan baik di semua aspek, pesertaPKP lebih banyak mengetahui dan memahami seperti apa pelaksanaan CPOBsecara real dalam sebuah Industri. Seperti Industri yang lainnya PT MedifarmaLaboratories juga memiliki masalah seperti berpikir bagaimana mengatasi wastetime pada proses maupun para pekerja sehingga suatu proses berlangsung lebihcepat tetapi tetap menghasilkan hasil yang baik dan dapat dipertanggungjawabkan,Oleh karena itu, Apoteker harus memiliki wawasan, pengetahuan dan kreatifitassehingga dapat mengatasi masalah-masalah tersebut.

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ABSTRACTProfession Internship at pharmaceutical industry was held at Quality Control (QC)Department of PT Medifarma Laboratories. This activity was held for two monthfrom July 1st until August 31th 2015. Profession internship at pharmaceuticalindustry was intended to make apothecary student understand the role ofpharmacist, have insight into the implementation of pharmaceutical practice,understand the implementation of Cara Pembuatan Obat yang Baik (CPOB), andknow the issues in pharmaceutical practice in pharmaceutical industry. Based onthe activities, Apothecary at QC Department is responsible for supervising thequality of the product diproduski and ensure that the necessary and relevant testshave been conducted and that the materials have not been approved are not used aswell as products that have not been approved are not sold or supplied before thequality was assessed and found eligible. Apothecary student have obtained insightinto general routine activities in QC Department, those were an analysis of thestarting materials, finished products, inspection of the starting material. Inperforming the task in QC department, apothecary student make a spreadsheet andvalidate them to support the analysis and inspection of the starting material. PTMedifarma Laboratories that has implemented the GMP well in all aspects, giveapothecary student more aware and understand what the real implementation ofGMP in an industry. Such as Industrial others, PT Medifarma Laboratories also hasa problem such as find solution how to solve waste time in the process or theworkers, so that a process was faster but still produce good results. Therefore,pharmacists should have the insight, knowledge and creativity so that can overcomethe problems.;Profession Internship at pharmaceutical industry was held at Quality Control (QC)Department of PT Medifarma Laboratories. This activity was held for two monthfrom July 1st until August 31th 2015. Profession internship at pharmaceuticalindustry was intended to make apothecary student understand the role ofpharmacist, have insight into the implementation of pharmaceutical practice,understand the implementation of Cara Pembuatan Obat yang Baik (CPOB), andknow the issues in pharmaceutical practice in pharmaceutical industry. Based onthe activities, Apothecary at QC Department is responsible for supervising thequality of the product diproduski and ensure that the necessary and relevant testshave been conducted and that the materials have not been approved are not used aswell as products that have not been approved are not sold or supplied before thequality was assessed and found eligible. Apothecary student have obtained insightinto general routine activities in QC Department, those were an analysis of thestarting materials, finished products, inspection of the starting material. Inperforming the task in QC department, apothecary student make a spreadsheet andvalidate them to support the analysis and inspection of the starting material. PTMedifarma Laboratories that has implemented the GMP well in all aspects, giveapothecary student more aware and understand what the real implementation ofGMP in an industry. Such as Industrial others, PT Medifarma Laboratories also hasa problem such as find solution how to solve waste time in the process or theworkers, so that a process was faster but still produce good results. Therefore,pharmacists should have the insight, knowledge and creativity so that can overcomethe problems."

"ABSTRAK Industri farmasi sebagai produsen produk obat memiliki peran besardalam peningkatan upaya kesehatan yaitu melalui pengadaan obat-obatan. Industrifarmasi memproduksi obat dengan berpedoman pada cara pembuatan obat yangbaik (CPOB). Industri farmasi harus memiliki minimal tiga orang apotekersebagai penanggungjawab masing-masing pada bidang pemastian mutu, produksi,dan pengawasan mutu. Tujuan praktik kerja profesi (PKP) ini supaya mahasiswaapoteker memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktisuntuk melakukan pekerjaan kefarmasian di industri farmasi dan paham penerapanCPOB. Mahasiswa apoteker di tempatkan di bagian quality assurance (QA) dan melakukan validasi metode pembersihan. Dari PKP yang dilakukan, mahasiswa PKP mendapat pengetahuan pekerjaan kefarmasian di industri farmasi,memperoleh keterampilan dalam melakukan validasi pembersihan alat, dan lebihmemahami penerapan aspek-aspek CPOB di industri farmasi. ABSTRACT The pharmaceutical industry as a manufacturer of medicinal products have

a major role in improving health efforts through drugs production. The

pharmaceutical industry produces drugs by referring to good manufacturing

product (GMP). The pharmaceutical industry must have at least three pharmacists

as a responsible in quality assurance, production and quality control. The purpose

of this internship programme are to get knowledge, skills, and practical experience

in the pharmaceutical industry and to understand the application of GMP. Student

was placed on the quality assurance (QA) and do cleaning validation. From the

internship, students gain knowledge of pharmaceutical jobs in the pharmaceutical

industry, acquire skills in performing cleaning validation tools, and better

understand the application of aspects of GMP in the pharmaceutical industry.;The pharmaceutical industry as a manufacturer of medicinal products have

a major role in improving health efforts through drugs production. The

pharmaceutical industry produces drugs by referring to good manufacturing

product (GMP). The pharmaceutical industry must have at least three pharmacists

as a responsible in quality assurance, production and quality control. The purpose

of this internship programme are to get knowledge, skills, and practical experience

in the pharmaceutical industry and to understand the application of GMP. Student

was placed on the quality assurance (QA) and do cleaning validation. From the

internship, students gain knowledge of pharmaceutical jobs in the pharmaceutical

industry, acquire skills in performing cleaning validation tools, and better

understand the application of aspects of GMP in the pharmaceutical industry.;The pharmaceutical industry as a manufacturer of medicinal products have

a major role in improving health efforts through drugs production. The

pharmaceutical industry produces drugs by referring to good manufacturing

product (GMP). The pharmaceutical industry must have at least three pharmacists

as a responsible in quality assurance, production and quality control. The purpose

of this internship programme are to get knowledge, skills, and practical experience

in the pharmaceutical industry and to understand the application of GMP. Student

was placed on the quality assurance (QA) and do cleaning validation. From the

internship, students gain knowledge of pharmaceutical jobs in the pharmaceutical

industry, acquire skills in performing cleaning validation tools, and better

understand the application of aspects of GMP in the pharmaceutical industry."