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"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."

"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 "

"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 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. "

"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. "

"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 PKPA merupakan kegiatan bagi mahasiswa apoteker untuk mempelajari secara langsung pekerjaan kefarmasian. PKPA di PT Actavis Indonesia bertujuan agar mahasiswa apoteker mengerti peran, tugas, dan tanggung jawab apoteker di industri farmasi; memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri; memahami penerapan CPOB di industri farmasi; dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. PKPA dilakukan selama 8 delapan minggu. Pada PKPA, mahasiswa melakukan pengamatan secara umum dan pengamatan secara langsung. Pengamatan secara umum dilakukan dengan menerima materi presentasi dari PT Actavis Indonesia, sedangkan pengamatan secara langsung dilakukan dengan mengunjungi suatu fasilitas di departemen terkait. Terdapat tugas khusus yang bertujuan untuk mengamati dan menganalisis permasalahan dari proses produksi Floxapen Dry Syrup; kemudian merekomendasikan tindakan perbaikan atau peningkatan pada proses produksi Floxapen Dry Syrup.

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ABSTRACTPharmacist Internship PKPA is an activity for pharmacist students to learn directly pharmaceutical job. PKPA in PT Actavis Indonesia aims to make students understand the role of the pharmacist, duties, and responsibilities of pharmacists in the pharmaceutical industry have the insight, knowledge, skills, and practical experience to do the job in the pharmaceutical industry understanding the application of GMP in the pharmaceutical industry and have a real picture of the problems of pharmaceutical job in the pharmaceutical industry. PKPA performed for 8 eight weeks. In PKPA, student performs general observation and direct observation. General observation is done by receiving teaching materials from PT Actavis Indonesia, whereas direct observations done by visiting a facility in relevant departments. There is a special task that aims to observe and analyze the problems of the production process of Floxapen Dry Syrup then recommend the corrective action or improvement in the production process of Floxapen Dry Syrup."

"ABSTRAKPraktek kerja profesi di Industri PT. Guardian Pharmatama yang dilaksanakan bulan Juli - September tahun 2016 bertujuan untuk 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 GMP CPOB di Industri Farmasi; dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Praktek kerja profesi ini juga ditunjang dengan tugas khusus yaitu pembuatan form rekonsiliasi produk, material kemas, dan bendera untuk departemen produksi di PT. Guardian Pharmatama. Tujuan dari tugas khusus ini adalah untuk mengetahui tata cara perhitungan rekonsiliasi, mengetahui cara pembuatan prosedur tetap di PT. Guardian Pharmatama, mempermudah manajemen PT. Guardian Pharmatama dalam melakukan investigasi produk, dan mencegah complain dari pelanggan terkait lolosnya sambungan foil pada strip atau blister.

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ABSTRACTInternship at PT. Guardian Pharmatama, was held on July September 2016, aims to understand the role, duties, and responsibilities of pharmacists at pharmaceutical industry to have knowledges, skills, and experience to do the pharmaceutical works at pharmaceutical industry to understand the application GMP CPOB at pharmaceutical industry and to have knowledge about the problem about pharmaceutical works at pharmaceutical industry. The internship also gives the author experience to do a special task about making a product reconciliation, packaging material reconciliation, and flags for production department at PT. Guardian Pharmatama. The special task aims to determine the procedure for calculation of reconciliation, knowing how to make Standard Operational Procedure SOP at PT. Guardian Phamatama, helping the managerial of PT. Guardian Pharmatama for product investigation, and prevention of complaining from consumer because the pass of foil connection at strip or blister."