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"Praktik kerja profesi sebagai apoteker industri dilakukan di PT Gratia Husada Farma bertujuan untuk memberikan pemahaman peranan, tugas, dan tanggung jawab apoteker di industri farmasi, memberikan wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi, memberikan pemahaman terhadap penerapan Cara Pembuatan Obat yang Baik CPOB di industri farmasi, serta memberikan gambaran nyata mengenai permasalahan pekerjaan kefarmasian di industri farmasi. Praktik kerja dilakukan selama dua bulan yang memberikan kesempatan kepada mahasiswa untuk terlibat langsung dalam seluruh tahapan yang dilakukan di industri farmasi. Mahasiswa diberikan tugas khusus dengan judul "Perencanaan Kapasitas Mesin Produksi Sediaan Farmasi dengan Analisis Downtime Mesin". Tujuan dari tugas khusus tersebut adalah menentukan downtime mesin produksi yang terjadi selama waktu operasional saat pengamatan dan menentukan jumlah output yang dapat ditingkatkan melalui analisis downtime mesin produksi.

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Internship as an industry pharmacist conducted at PT Gratia Husada Farma aims to provide an understanding of the role, duties and responsibilities of pharmacists in the pharmaceutical industry, providing insight, knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry, applying Good Manufacturing Practices GMP in the pharmaceutical industry, as well as provide a clear picture of the pharmaceutical work pharmaceutical industry. The internship is conducted for two months giving students the opportunity to be directly involved in all phases in the pharmaceutical industry. Students are given a special assignment entitled Planning Capacity of Pharmaceutical Production Machinery with Downtime Analysis of Machine. The purpose of this particular assignment is to determine the downtime of the production machine during the operational time during observation and to determine the amount of output that can be increased through the analysis of production machine downtime. "

"Praktik kerja profesi di PT Gratia Husada Farma Periode Bulan Februari ndash; Maret Tahun 2018 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 "Perencanaan Kapasitas Mesin Produksi Sediaan Farmasi dengan Analisis Downtime Mesin". Tujuan dari pelaksanaan tugas khusus di PT Gratia Husada Farma adalah meningkatkan kapasitas mesin produksi berdasarkan hasil pengamatan downtime mesin. Secara umum, PT Gratia Husada Farma telah menerapkan 12 aspek CPOB dengan baik dan benar, penulis juga telah mendapatkan kemampuan untuk memahami peran, tugas, wawasan dan tanggung jawab apoteker dan memberikan solusi pada permasalahan di industri farmasi.

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Internship at PT Gratia Husada Farma Plant Period February - March 2018 aims to understand the duties and responsibilities of pharmacists in the pharmaceutical industry and the understanding of the application of goodmanufacturing 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 "Pharmaceutical Production Machine Capacity Planing Through Downtime Analysis". The purpose of this special assignment is to improve the production machine capacity based on the downtime analysis. In general, PT Gratia Husada Farma has applied authors also have the ability to responsibilities of pharmacists and pharmacy 12 aspects of GMP well and correctly, the understand the roles, duties, insights and provide solutions on products in the industry. "

"[Berdasarkan Peraturan Menteri Kesehatan Republik Indonesia Nomor 1799 Menkes Per XII 2010 proses pembuatan obat dan atau bahan obat hanya dapat dilakukan oleh Industri Farmasi yakni badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat Pada pelaksanaannya industri farmasi harus menerapkan Cara Pembuatan Obat yang Baik CPOB yang bertujuan untuk menjamin obat dibuat secara konsisten memenuhi persyaratan yang ditetapkan dan sesuai dengan tujuan penggunaannya CPOB terdiri atas 12 pilar yang CPOB mencakup seluruh aspek produksi dan pengendalian mutu Pada pembuatan obat pengendalian secara menyeluruh merupakan hal yang sangat esensial untuk menjamin bahwa konsumen menerima obat yang bermutu tinggi Praktek Kerja Profesi Apoteker yang dilaksanakan di PT Gratia Husada Farma HUFA telah memberikan pemahaman bahwa Apoteker dapat berperan penting di industri farmasi yakni dalam hal manajemen teknis saat pelaksanaan produksi dan pengawasan Selain itu apoteker juga dapat berperan dalam pengembangan produk perencanaan produksi serta penyimpanan barang Kegiatan PKPA ini diharapkan dapat meluluskan calon Apoteker yang berkualitas dan berdaya saing tinggi sehingga dapat menerapkan current Good Manufacturing Practice cGMP untuk menghasilkan produk yang memenuhi syarat Quality Safety dan Efficacy QSE ;Based on the Regulation of the Minister of Health of the Republic of Indonesia Number 1799 Menkes Per XII 2010 the manufacturing process of drugs and or drug ingredients only be carried out by the Pharmaceutical Industry the business entity that has a license from the Minister of Health to conduct the manufacture of drugs or drug ingredients In practice the pharmaceutical industry must implement the Good Manufacturing Practice GMP which aims to ensure the drugs are made consistently meet the requirements set and in accordance with the intended use GMP consists of 12 pillars that covers all aspects of production and quality control In the manufacture of drugs overall control is very essential to ensure that consumers receive high quality drugs Apothecary Profession Profession PKPA conducted at PT Gratia Husada Farma HUFA has given the understanding that pharmacists can play an important role in the pharmaceutical industry in terms of management current technical production implementation and supervision In addition pharmacists can also play a role in product development production planning as well as the storage of goods PKPA activity is expected to pass Pharmacists qualified candidates and competitive so as to apply the current Good Manufacturing Practice cGMP to produce products that meet the requirements of Quality Safety and Efficacy QSE ;Based on the Regulation of the Minister of Health of the Republic of Indonesia Number 1799 Menkes Per XII 2010 the manufacturing process of drugs and or drug ingredients only be carried out by the Pharmaceutical Industry the business entity that has a license from the Minister of Health to conduct the manufacture of drugs or drug ingredients In practice the pharmaceutical industry must implement the Good Manufacturing Practice GMP which aims to ensure the drugs are made consistently meet the requirements set and in accordance with the intended use GMP consists of 12 pillars that covers all aspects of production and quality control In the manufacture of drugs overall control is very essential to ensure that consumers receive high quality drugs Apothecary Profession Profession PKPA conducted at PT Gratia Husada Farma HUFA has given the understanding that pharmacists can play an important role in the pharmaceutical industry in terms of management current technical production implementation and supervision In addition pharmacists can also play a role in product development production planning as well as the storage of goods PKPA activity is expected to pass Pharmacists qualified candidates and competitive so as to apply the current Good Manufacturing Practice cGMP to produce products that meet the requirements of Quality Safety and Efficacy QSE , Based on the Regulation of the Minister of Health of the Republic of Indonesia Number 1799 Menkes Per XII 2010 the manufacturing process of drugs and or drug ingredients only be carried out by the Pharmaceutical Industry the business entity that has a license from the Minister of Health to conduct the manufacture of drugs or drug ingredients In practice the pharmaceutical industry must implement the Good Manufacturing Practice GMP which aims to ensure the drugs are made consistently meet the requirements set and in accordance with the intended use GMP consists of 12 pillars that covers all aspects of production and quality control In the manufacture of drugs overall control is very essential to ensure that consumers receive high quality drugs Apothecary Profession Profession PKPA conducted at PT Gratia Husada Farma HUFA has given the understanding that pharmacists can play an important role in the pharmaceutical industry in terms of management current technical production implementation and supervision In addition pharmacists can also play a role in product development production planning as well as the storage of goods PKPA activity is expected to pass Pharmacists qualified candidates and competitive so as to apply the current Good Manufacturing Practice cGMP to produce products that meet the requirements of Quality Safety and Efficacy QSE ]"

"ABSTRAKPerkembangan dunia kesehatan terutama obat semakin berkembang seiring berjalannya waktu. Harapan masyarakat terhadap kualitas dan keamanan obat juga menjadi lebih tinggi. Industri farmasi memiliki peran dan tanggung jawab terbesar terkait efikasi, keamanan, kualitas dan mutu obat. Dalam penerapan CPOB di industri farmasi, apoteker memegang peran yang penting terutama dalam tugas produksi, pengawasan mutu dan pemastian mutu yang harus dipimpin oleh seorang apoteker. Oleh sebab itu mahasiswa calon apoteker harus berkompeten serta menguasai pengetahuan dan keterampilan yang baik untuk dapat menerapkan CPOB di dalam industri farmasi. Pengetahuan yang didapat mahasiswa selama praktek kerja profesi PT Gratia Husada Farma terkait pekerjaan kefarmasian di industri farmasi, seperti memahami pengembangan obat baru atau trial dan metode pengujiannya, mengikuti alur penerimaan, pengeluaran dan penyimpanan bahan awal dan produk jadi, alur proses produksi obat dan manajemennya, sistem penunjang, dan pengawasan serta penjaminan mutu.

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ABSTRACTThe development of health care and technology, especially drugs, has grown over time. Public expectations of drug quality and safety are also higher. The pharmaceutical industry has the greatest roles and responsibilities related to the efficacy, safety and quality of the drug. In the application of GMP in the pharmaceutical industry, pharmacists have an important role especially in the task of production, quality control and quality assurance that must be led by a pharmacist. Therefore, pharmacist students must be competent and have good knowledge and skills to do the GMP in the pharmaceutical industry. Knowledge gained by student during the professional practice in PT Gratia Husada Farma Semarang is all related to pharmaceutical practice in the pharmaceutical industry, such as understanding the development of new drugs or trials and test methods, knowing the flow of acceptance and storage of raw materials and finished products, the flow of the drug production process and its management, the support systems, the quality control and quality assurance"

"ABSTRAKIndustri Farmasi memiliki peran strategis dalam usaha pelayanan kesehatan kepada masyarakat. Proses pembuatan obat maupun penggunaan bahan obat hanya dapat dilakukan oleh badan usaha yang telah memiliki izin, yakni Industri Farmasi. Industri farmasi dituntut untuk terus meningkatkan kuantitas dan kualitas obat dengan adanya penerapan CPOB Cara Pembuatan Obat yang Baik . membuat Sumber daya manusia personalia yang memegang peranan penting di Industri Farmasi adalah Apoteker. Melalui Praktek Kerja Profesi Apoteker PKPA , Apoteker dituntut untuk mempunyai wawasan, pengetahuan dan pengalaman praktis yang memadai serta kemampuan dalam memimpin agar dapat mengatasi permasalahan permasalahan yang ada di industri farmasi. Praktik Kerja Profesi ini dilakukan selama dua bulan di PT Gratia Husada Farma HUFA , Semarang. Setelah melakukan praktik kerja profesi, Apoteker mengetahui tugas dan tanggung jawab Apoteker di bidang managerial maupun operasional. Memiliki ketrampilan seperti pembuatan pengkajian mutu produk, mengikuti alur proses produksi, serta mengetahui masalah terkait manajemen personil, operasional, mesin dan biaya

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ABSTRACTPharmaceutical Industry has strategic role in health services to the community. Medicine or medicinal materials manufacturing process, only can be done by licensed business entity, in this case is the pharmaceutical industry. Pharmaceutical industry is in charge to keep their quantity and quality with GMP Good Manufacturing Process implementation. Human resources personalia that play important role in the pharmaceutical industry was the Pharmacist. By internship at PT Gratia Husada Farma, Pharmacist is in charge to have adequate insight, knowledge, dan practical experience, and also ability to guide in order to overcome the problems that exist in the pharmaceutical industry. This internship was done for two months at PT Gratia Husada Farma HUFA , Semarang. After the internship, the Pharmacist knew their duty and responsibility in managerial and operational area. Having skills such as making product quality review, following production process, and also knew related issues about personalia, operational, machine and budgeting management "

"Praktik kerja profesi di PT. Finusolprima Farma Internasional Periode Bulan Februari ndash; Maret Tahun 2018 bertujuan agar calon Apoteker memahami tugas dan tanggung jawab apoteker di industri farmasi, penerapan Cara Pembuatan Obat yang Baik CPOB di industri farmasi, serta memahami permasalahan dan strategi penyelesaian yang dihadapi di Industri Farmasi. Tugas khusus yang diberikan yaitu berjudul ldquo;Gap Analysis Antara Kondisi Aktual di PT. Finusolprima Farma Internasional terhadap Regulasi PIC/S, CPOB, TRS, dan EU Guidelines rdquo;. Tujuan dari pelaksanaan tugas khusus adalah memahami regulasi terkait pembuatan obat di berbagai negara dengan kondisi aktual yang terjadi di industri beserta pemenuhan nya terhadap regulasi tersebut. Secara umum, PTFinusolprima Farma Internasionaltelah menerapkan 12 aspek CPOB dengan baik dan benar.

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Internshipat PT. Finusolprima Farma International Period February - March 2018 aims to prospective Pharmacists understand the duties and responsibilities of pharmacists in the pharmaceutical industry, the implementation of Good Manufacturing Practices GMP in the pharmaceutical industry, and understand the problems and settlement strategies faced in the Pharmaceutical Industry. The special task given is entitled Gap Analysis Between Actual Conditions in PT. Finusolprima Farma International against Regulation of PIC/S, CPOB, TRS, and EU Guidelines . The purpose of the implementation of specific tasks is to understand the regulations related to the manufacture of drugs in various countries with the actual conditions occurring in the industry and its compliance with the regulation. In general, PT Finusolprima Farma International has applied 12 aspects of GMP well and correctly."

"ABSTRAKPraktik Kerja Profesi di PT. Finusolprima Farma Internasional Periode Bulan Februari-Maret Tahun 2018 bertujuan agar para calon Apoteker dapat memahami peranan, tugas, dan tanggung-jawab apoteker di Industri Farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri, memahami penerapan Cara Pembuatan Obat yang Baik di Industri Farmasi dan memiliki gambaran nyata tentang permasalahan serta mempelajari strategi dan kegiatan-kegiatan yang dapat dilakukan dalam pekerjaan kefarmasian di Industri Farmasi. Praktik Kerja Apoteker ini dilaksanakan selama 2 dua bulan dengan tugas khusus berjudul ldquo;Gap Analysis antara Kondisi Aktual di PT. Finusolprima Farma Internasional terhadap Regulasi PIC/S, CPOB, TRS, dan EU Guidelines rdquo;. Tujuan dari tugas khusus ini adalah untuk untuk mengetahui adanya perbedaan/gap antara standar regulasi yang berlaku terhadap kondisi aktual yang dilakukan di PT. Finusolprima Farma Internasional.

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ABSTRACTInternship at PT. Finusolprima Farma Internasional Period of February - March 2018 aims to let future pharmacist understand the roles, duties, and responsibilities of pharmacists in the pharmaceutical industry. this also let future pharmacist to have insight, knowledge, skills and practical experience to do pharmaceutical practice in the industry, understand the application of Godd Manufacturing Practice GMP/CPOB in the real life and have a real description of existing problem and learn the strategies and activities that can be done in pharmacy practice in Pharmaceutical Industry. This internship is carried out for 2 two months with a special assignment entitled Gap Analysis between Actual Conditions at PT. Finusolprima Farma Internasional to the PIC / S, CPOB, TRS and EU Guidelines Regulations . The purpose of this particular task is to find out the differences between the applicable regulatory standards and the actual conditions that have been done at PT. Finusolprima Farma Internasional. "

"ABSTRAKPraktik Kerja Profesi Apoteker di PT Actavis Indonesia Periode Februari ndash; Maret 2018 bertujuan untuk memahami peranan CPOB dalam industri farmasi, mengerti peranan nyata sebagai seorang apoteker di industri farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefaarmasian di industri farmasi, dan memiliki gambaran nyata tentang permsalahan pekerjaan kefarmasian di industri farmasi. Tugas khusus yangdiberikan yaitu berjudul ldquo;Gap Analysis Pemantauan Lingkungan rdquo;. Tujuan dari pelaksanaan tugas khusus di PT Guardian Pharmatama adalah mencari gap yang ada antara CPOB yang dipakai di Indonesia dengan CPOB/GMP yang ada di dunia seperti GMP di Eropa, Singapura, PIC/S, dan WHO terkait pemantauan tekanan, suhu, kelembapan, jumlah partikel, cemaran mikroba, dan pertukaran udara, dan membuat rangkuman analisis untuk perbedaan CPOB terkait pemantauan tekanan, suhu, kelembapan, jumlah partikel, cemaran mikroba, dan pertukaran udara di Indonesia dan luar Indonesia. Secara umum, pekerjaan kefarmasian yang dilakukan di PT. Actavis Indonesia menerapkan pedoman CPOB dan selalu melakukan pembaharuan jika ada peraturan yang berubah, danpermasalahan yang dihadapi oleh seorang apoteker di industri farmasi adalah memastikan bahwa CPOB sudah diterapkan dengan baik

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ABSTRACT Internship at PT Actavis Indonesia period February - March 2018 aims to understand the role of CPOB in the pharmaceutical industry, understand the real role of pharmacist in the pharmaceutical industry, have the insight, knowledge, skills and practical experience to carry out pharmaceutical work in the pharmaceutical industry, and has a clear picture of the pharmaceutical workplace pharmaceutical issues. The specific task given is entitled Gap Analysis of Environmental Monitoring . The purpose of performing specific tasks at PT Guardian Pharmatama is to look for existing gaps between the CPOBs used in Indonesia and the worldwide CPOB / GMP such as GMP in Europe, Singapore, PIC / S and WHO on monitoring pressure, temperature, humidity, particle, microbial contamination, and air exchange, and make a summary of the analysis for differences in CPOBs related to monitoring of pressure, temperature, humidity, particle count, microbial contamination, and air exchange in Indonesia and outside Indonesia. In general, pharmaceutical work done at PT. Actavis Indonesia applies the CPOB guidelines and keeps up-to-date with any regulations that change, and the problems faced by a pharmacist in the pharmaceutical industry is to ensure that the CPO B is well implemented "

"ABSTRAKPraktik kerja profesi di PT Guardian Pharmatama Periode Bulan Februari-Maret Tahun 2018 bertujuan untuk mengetahui tugas dan tanggung jawab apoteker di industri farmasi dan memahami penerapan Cara Pembuatan Obat yang Baik CPOB di Industri Farmasi. Selain itu calon apoteker juga dapat memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industry farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang diberikan yaitu berjudul Laporan Validasi Proses Pengolahan dan Pengemasan Krim Mometasone Furoate 10 Gram OGB dan Suspensi 10 mL rdquoTujuan dari pelaksanaan tugas khusus di PT Guardian Pharmatama adalah mengamati dan mengevaluasi kegiatan pengolahan dan pengemasan Krim Mometasone Furoate 10 gram OGB dan Suspensi merupakan proses yang valid dan dapat memberikan hasil yang konsisten. Secara umum, PT Guardian Pharmatama telah menerapkan 12 aspek CPOB dengan baik dan benar, penulis juga telah mendapatkan kemampuan untuk memahami peran, tugas, wawasan dan tanggung jawab apoteker dan memberikan solusi pada permasalahan di industri farmasi.

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ABSTRACTInternship at PT Guardian Pharmatama Period February-March 2018 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 Manufacturing and Packaging Process Validation Report of Mometasone Furoate 10 Gram Cream OGB and Suspension X 10 mL.The purpose of this special assignment is to observe and to evaluate the manufacturing and packaging process of Mometasone Furoate 10 gram OGB and Suspension can yield a constant and valid through out its operation. In general, PT Guardian Pharmatama has applied 12 aspects of GMP well and correctly, the authors also have the ability to understand the roles, duties, insights and responsibilities of pharmacists and provide solutions on products in the industry pharmacy."

"Seorang apoteker memegang peranan penting dalam industri farmasi dan apotek. Apoteker harus memenuhi standar kompetensi sebagai persyaratan untuk menjalankan pekerjaan kefarmasian. Dalam rangka pencapaian standar kompetensi tersebut, calon apoteker harus menjalankan Praktik Kerja Profesi Apoteker (PKPA). PKPA dilaksanakan di PT Finusolprima Farma Internasional dan Apotek Yosa Medika selama periode Februari-Mei 2020. Setelah melaksanakan PKPA diharapkan calon Apoteker dapat memperoleh wawasan, pemahaman, dan pengalaman dalam menjalankan pekerjaan kefarmasian.

 

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A pharmacist plays an important role in the pharmaceutical industry and pharmacy. Pharmacists must meet competency standards as a requirement for carrying out pharmaceutical work. In order to achieve these competency standards, prospective pharmacists must carry out Pharmacist Professional Work Practices (PKPA). PKPA is held at PT Finusolprima Farma Internasional and Yosa Medika Pharmacy during the February-May 2020 period. After completing PKPA, it is hoped that Pharmacist candidates can gain insight, understanding and experience in carrying out pharmaceutical work."