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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 PT Kimia Farma Tbk. Unit Research and Development dilaksanakan pada periode 2 Februari - 13 Maret 2015, bertujuan agar mahasiswa calon apoteker mengerti peranan, tugas, dan tanggung jawab Apoteker di industri farmasi khususnya di PT Kimia Farma Tbk. Unit Research and Development, memahami penerapan CPOB di industri farmasi, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Pada PKP ini juga diberikan tugas khusus yaitu berupa studi preformulasi dan formulasi tablet vitamin K3 (Menadion Natrium Bisulfit) 10 mg.

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ABSTRACTProfession Internship (PKP) at PT Kimia Farma Tbk. Research and Development Unit on February 2nd - March 13th 2015, aims to make students understand about the role of the prospective, duties, and responsibilities of pharmacist in pharmaceutical industries specifically in PT. Kimia Farma Tbk. Research and Development Unit, understanding the application of GMP in the in pharmaceutical industries, and have a real picture about the problem of pharmaceutical jobs in pharmaceutical industries. The special assignment of this PKP was preformulation and formulation study of Tablets Vitamine K3 (Menadione Sodium Bisulfite) 10 mg., Profession Internship (PKP) at PT Kimia Farma Tbk. Research and Development Unit on February 2nd - March 13th 2015, aims to make students understand about the role of the prospective, duties, and responsibilities of pharmacist in pharmaceutical industries specifically in PT. Kimia Farma Tbk. Research and Development Unit, understanding the application of GMP in the in pharmaceutical industries, and have a real picture about the problem of pharmaceutical jobs in pharmaceutical industries. The special assignment of this PKP was preformulation and formulation study of Tablets Vitamine K3 (Menadione Sodium Bisulfite) 10 mg.]"

"[ABSTRAKApoteker merupakan salah satu tenaga inti dalam industri farmasi yang turut berperan dalam menghasilkan obat yang bermutu aman dan berkhasiat CPOB mengemukakan bahwa terdapat beberapa kedudukan apoteker di industri yaitu Penanggung jawab produksi pengawasan mutu dan pemastian mutu Apoteker dituntut untuk mempunyai pengetahuan keterampilan dan kemampuan dalam mengaplikasikan dan mengembangkan ilmunya secara professional agar dapat mengatasi permasalahan permasalahan yang ada di industri farmasi Selama praktek kerja di PT Taisho Pharmaceutical Indonesia Tbk mahasiswa calon Apoteker dapat mengambil manfaat dan ilmu sebanyak mungkin mengenai industri farmasi sehingga dapat diaplikasikan dengan baik untuk pengembangan ilmu kefarmasian Tugas khusus yang didapatkan selama praktek kerja di PT Taisho Pharmaceutical Indonesia Tbk adalah membuat usulan standar prosedur operasional rework dan redress

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ABSTRACTPharmacists are one of the core force in the pharmaceutical industry that played a role in Generating drug quality safety and efficacy GMP argued that there are some pharmacists position in the industry which is undertaking production quality control and quality assurance Pharmacists are required to have the knowledge skills and ability to apply and develop their knowledge in a professional manner in order to overcome the problems that exist in the pharmaceutical industry During practice at PT Taisho Pharmaceutical Indonesia Tbk prospective pharmacist students may benefit as much knowledge as possible about the pharmaceutical industry so that it can be applied well to the development of pharmaceutical science Special task obtained during practise at PT Taisho Pharmaceutical Indonesia Tbk is making proposal of standard operational procedure of rework and redress , Pharmacists are one of the core force in the pharmaceutical industry that played a role in Generating drug quality safety and efficacy GMP argued that there are some pharmacists position in the industry which is undertaking production quality control and quality assurance Pharmacists are required to have the knowledge skills and ability to apply and develop their knowledge in a professional manner in order to overcome the problems that exist in the pharmaceutical industry During practice at PT Taisho Pharmaceutical Indonesia Tbk prospective pharmacist students may benefit as much knowledge as possible about the pharmaceutical industry so that it can be applied well to the development of pharmaceutical science Special task obtained during practise at PT Taisho Pharmaceutical Indonesia Tbk is making proposal of standard operational procedure of rework and redress ]"

"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. "