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"Obat yang dihasilkan oleh industri farmasi harus memenuhi persyaratan khasiat efficacy, keamanan safety, dan mutu quality. Berdasarkan Peraturan Pemerintah nomor 51 tahun 2009 tentang pekerjaan kefarmasian, apoteker menjadi personil kunci pada bagian produksi, pengawasan mutu serta pemastian mutu. Sehingga sebagai personil kunci, seorang apoteker harus memiliki pengetahuan dan pengalaman yang cukup mengenai industri farmasi sebelum terjun langsung ke industri farmasi yang sebenarnya. Dalam melakukan proses pembuatan obat, suatu industri farmasi harus menerapkan seluruh aspek yang terdapat dalam Cara Pembuatan Obat yang Baik CPOB karena CPOB merupakan standar dalam proses pembuatan obat di Indonesia yang bertujuan untuk memastikan agar mutu obat yang dihasilkan sesuai dengan persyaratan dan tujuan penggunaan. Departemen pemastian mutu atau biasa disebut quality assurance QA merupakan departemen yang strategis bagi calon apoteker untuk belajar mengenai penerapan CPOB di industri farmasi. Quality Assurance merupakan departemen yang bertanggungjawab untuk menjamin agar produk berkualitas, aman, berkhasiat, sesuai dengan tujuan penggunaan, serta sesuai dengan izin edar. Departemen QA melaksanakan kegiatan-kegiatan yang bertujuan untuk menjamin kualitas produk salah satunya adalah melakukan validasi seperti validasi proses dan pembersihan. Tugas khusus yang dilakukan adalah membuat protokol dan laporan validasi sediaan cair dan pembuatan study waktu tunggu bersih mesin.

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Drugs that manufactured by the pharmaceutical industry should meet the requirements of efficacy, safety and quality. Based on Government Regulation number 51 year 2009 about pharmaceutical work, pharmacist become key personnel in production, quality control and quality assurance. As the key personnel, a pharmacist should possessed a good knowledge and enough experience in pharmaceutical industry before plunging directly into the actual pharmaceutical industry. A pharmaceutical industry in manufacturing drugs should based on Good Manufacturing Practice GMP because GMP is the standard in Indonesian drug manufacturing process which aimed to ensure the quality of the medicine produced is in accordance with the terms and purposes of use. Quality assurance is a strategic department for prospective pharmacist to learn about the application of GMP in pharmaceutical industry. Quality Assurance responsible in ensuring the product rsquo s quality, safety, efficacy and in accordance with the purpose of the use and in accordance with the marketing authorization. One of the activities that QA department conducted to ensure the quality of the product is validation such as process validation and cleaning validation. The special assignment undertaken are to make protocol and validation report of liquid products and also study of machine clean holding time."

"Praktik Kerja Profesi di PT Kalbe Farma Tbk Periode Bulan Januari - 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 ldquo;Pembuatan Lembar Kerja Analisis Analytical Worksheet untuk Bahan Baku rdquo;. Tujuan dari pelaksanaan tugas khusus di PT Kalbe Farma Tbk adalah untuk memahami tahapan proses prakualifikasi WHO dan memahami dokumen yang dibutuhkan dalam proses prakualifikasi WHO dan cara pembuatan dokumen tersebut. Secara umum, PT Kalbe Farma Tbk telah menerapkan 12 aspek CPOB dengan baik dan benar, penulis juga telah mendapatkan kemampuan untuk memahami peran, tugas, wawasan dan tanggung jawab apoteker di industri farmasi.

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Internship at PT Kalbe Farma Tbk Period January - 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 ldquo;Making Analytical Worksheet for Raw Materials rdquo;. The purpose of this special assignment is to understand the phases of the WHO prequalification process and understand the documents required in the WHO prequalification process and the way in which the document are produced. In general, PT Kalbe Farma Tbk 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 in the industry pharmacy. "

"Praktik kerja profesi di PT Kalbe Farma, Tbk. yang dilaksanakan pada bulan Januari hingga Maret 2018 bertujuan untuk memahami peranan, tugas, dan tanggung jawab apoteker di industri farmasi serta mendapatkan pengalaman praktis untuk melakukan pekerjaan kefarmasian dan penerapan Cara Pembuatan Obat yang Baik CPOB di industri farmasi, sehingga calon apoteker dapat melihat gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang diberikan adalah ldquo;Pembuatan Total Productive Maintenance TPM Pocket Book serta Modul Mesin Cetak Tablet, Mesin Pembuat Larutan Coating, dan Mesin Coating Tablet Line 8A rdquo;. Tujuan dari pelaksanaan tugas khusus di PT Kalbe Farma, Tbk. adalah membantu karyawan baru Departemen Produksi untuk mengenal dan memahami pentingnya TPM dan membantu karyawan baru, yaitu operator mesin di Line 8A, untuk mengenal dan memahami fungsi, bagian-bagian, cara mengoperasikan, serta cara membersihkan mesin cetak tablet dan mesin coating tablet. Dari praktik kerja profesi ini dapat disimpulkan bahwa PT Kalbe Farma, Tbk. telah menerapkan 12 aspek CPOB dengan baik dan benar, serta penulis dapat memahami peranan, tugas, dan tanggung jawab apoteker, penerapan CPOB, permasalahan dalam pekerjaan kefarmasian, dan bagaimana apoteker bertindak untuk menyelesaikan permasalahan yang ada di industri farmasi.

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Internship at PT Kalbe Farma, Tbk. which conducted in January to March 2018 aims to understand the role, duties, and responsibilities of pharmacists in the pharmaceutical industry and gain practical experience to undertake pharmaceutical work and the application of Good Manufacturing Practices GMP in the pharmaceutical industry so that the pharmacist candidates can see the real concerns about pharmaceutical work in the pharmaceutical industry. The special assignment given is Creating Total Productive Maintenance TPM Pocket Book and Modules of Tabletting Machines, Coating Solution Mixers, and Tablet Coating Machines in Line 8A . The purposes of this special assignment in PT Kalbe Farma, Tbk. are to help new employees of the Production Department to recognize and understand the importance of TPM and assist new employees, whom machine operators in Line 8A, to know and understand the functions, parts, how to operate, how to clean the tabletting machines and tablet coating machines. From this internship, it can be concluded that PT Kalbe Farma, Tbk. has implemented the 12 aspects of CPOB well and correctly, and the author can understand the role, duties and responsibilities of pharmacists, the application of GMP, the problems in pharmaceutical work, and how pharmacists act to solve the problems in the pharmaceutical industry."

"ABSTRAKPraktik Kerja Profesi Apoteker PKPA di Corporate Business Development PT. Kalbe Farma, Tbk. dilaksanakan dengan tujuan agar mahasiswa Program Studi Profesi Apoteker memahami tugas dan peran apoteker di industri farmasi terutama pada bidang pengembangan bisnis, juga memperoleh wawasan dan pengalaman praktis bekerja di corporate business development industri farmasi. Tugas khusus dibuat untuk memberikan rekomendasi pengembangan bisnis dari produk perawatan kesehatan kulit berbasis herbal berdasarkan analisis situasi pasar menggunakan analisis stratejik yaitu analisa eksternal dan internal PT. Kalbe Farma, Tbk.

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ABSTRACTPharmacist Internship Program at Corporate Business Development PT. Kalbe Farma, Tbk. was held with the aim that students of Apothecary Study Program understand the duties and roles of pharmacist at the pharmaceutical industry especially in the field of business development, also gain insight and practical experience working in the business development of the pharmaceutical industry. Specific assignment are created to provide business development recommendations of herbal skincare products based on market analysis using strategic analysis i.e. external and internal analysis of PT. Kalbe Farma, Tbk."

"Praktik kerja profesi di PT Kalbe Farma Tbk Cikarang Periode Bulan Maret - April Tahun 2018 bertujuan untuk 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 CPOB di Industri Farmasi, serta memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Praktik kerja profesi ini dilaksanakan selama delapan minggu dengan tugas khusus yaitu ldquo;Pembuatan Modul Pengoperasian dan Pembersihan Mesin Produksi sebagai Media Training pada Tahap Autonomous Maintenance menggunakan Software Articulate Storyline rdquo;. Tujuan dari tugas khusus ini adalah untuk membuat modul pengoperasian dan pembersihan mesin produksi sebagai media training bagi operator menggunakan software articulate storyline, mengetahui langkah-langkah yang dilakukan dalam pembuatan modul mesin produksi, dan memperoleh standarisasi konten isi modul mesin produksi.

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Internship at PT Kalbe Farma Tbk Cikarang Period March - April 2018 aims to understand the role, duties and responsibilities of pharmacists in the Pharmaceutical Industry, have insight, knowledge, skills and practical experience to do pharmaceutical practices in Pharmaceutical Industry, understand the application of CPOB in Pharmaceutical Industry, and get an experience of the pharmaceutical practice issues in the Pharmaceutical Industry. . Internship was done for eight weeks with an assignment about Making an Operating and Cleaning Machine Module as Media Training of Autonomous Maintenance using Articulate Storyline Software . The purpose of this assigment is to make an operating and cleaning machine module as a training media for operators using the articulate storyline software, knowing the steps taken in making the production machine module, and getting the content standardization of the production machine module contents."

"Peluang bisnis dalam industri farmasi di Indonesia membuat PT. Kalbe Farma Tbk. sebagai salah satu perusahaan farmasi terbesar di Indonesia dituntut untuk terus mengembangkan diri dengan menciptakan produk-produk yang inovatif dengan mutu terbaik untuk konsumen. Dalam pelaksanaannya, PT Kalbe Farma Tbk memiliki divisi Corporate Business Development CBD . Divisi ini berperan dalam proses hulu menuju hilir dari produk-produk yang dikembangkan di PT. Kalbe Farma Tbk. Sumber daya manusia yang kompeten di bidang kesehatan merupakan komponen kunci dalam CBD Kalbe Farma, di mana salah satunya adalah Farmasi. Anggota Corporate Business Development dituntut untuk memiliki kemampuan analisis dan pengetahuan yang mendalam di bidang bisnis kesehatan yang sedang berkembang untuk dianalisis dan dikembangkan menjadi produk jadi. Kompetensi tersebut penting dimiliki oleh calon apoteker. Untuk memberikan gambaran pekerjaan CBD Kalbe Farma, diberikan tugas khusus berupa Analisis Pasar Minyak Esensial. Pasar minyak esensial dikaji secara stratejik dengan analisis eksternal dan analisis internal untuk menentukan kelayakannya untuk dikembangkan sebagai produk jadi. Berdasarkan analisis eksternal dan internal, minyak esensial layak untuk dikembangkan menjadi produk jadi karena berbagai kelebihannya sebagai produk kesehatan dan besarnya peluang untuk pasar ini.

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Business opportunities in the pharmaceutical industry in Indonesia made PT. Kalbe Farma Tbk. as the largest pharmaceutical company in Indonesia are required to continue to develop themselves by creating innovative products with the best quality for consumers. In its implementation, PT Kalbe Farma Tbk has a Corporate Business Development CBD division. This division plays a role in the upstream process leading to downstream process of products developed at PT. Kalbe Farma Tbk. Competent human resources in the health sector are the key components in Kalbe Farma CBD, where one of them is Pharmacy. Members of Corporate Business Development are required to have deep analytical and knowledge capabilities in the emerging field of healthcare business, able to analyze and develop an idea into the finished products. These competencies are important to be possessed by prospective pharmacists. To provide an overview of Kalbe Farma 39 s CBD works, a specific assignment entitled of Essential Oil Market Analysis was given. Essential oil markets are studied strategically with external analysis and internal analysis to determine their feasibility to be developed as the finished product. Based on external and internal analyzes, essential oils deserved to be developed into finished products due to their various advantages as health products and the magnitude of opportunities for this market. "

"ABSTRAKIndustri farmasi merupakan salah satu faktor penting dalam ketersediaan obat. Dalam melakukan kegiatannya, industri farmasi harus menerapkan Cara Pembuatan Obat yang Baik CPOB . Salah satu aspek pada CPOB adalah personalia. Oleh karena itu, apoteker berperan penting sebagai personil kunci dalam industri farmasi yaitu kepala bagian produksi, kepala bagian pemastian mutu, dan kepala bagian pengawasan mutu. Untuk memperoleh gambaran lebih jelas mengenai peran apoteker dalam industri farmasi, PT. Kalbe Farma, Tbk. memberikan kesempatan bagi calon apoteker untuk melaksanakan praktek kerja profesi. Setelah praktik kerja, calon apoteker diharapkan dapat memahami peran apoteker di industri farmasi dan memiliki pengetahuan, keterampilan, danpengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi.

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ABSTRACT

The pharmaceutical industry is one of the important factors in the availability of drugs. In conducting its activities, the pharmaceutical industry must apply Good Manufacturing Practice GMP . One aspect of the GMP is personnel. Therefore, the pharmacist plays an important role as a key personnel in the pharmaceutical industry namely the head of production, the head of quality assurance, and the head of quality control. To obtain a clearer picture of the role of pharmacists in the pharmaceutical industry, PT. Kalbe Farma, Tbk. provides an opportunity for prospective pharmacists to carry out professional work practices. After the internship, prospective pharmacists are expected to understand the role of pharmacists in the pharmaceutical industry and have the knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry."

"Profesi apoteker memiliki peran penting dalam industri farmasi, rumah sakit, pelayanan, dan pemerintahan. Seorang calon Apoteker harus melakukan Praktik Kerja Profesi Apoteker agar mendapatkan bekall dan pengalaman yang diperlukan untuk menjadi Apoteker yang professional dalam memasuki dunia pekerjaan. Praktik Kerja Profesi Apoteker dilaksanakan di PT. Takeda Indonesia periode Bulan Januari – Maret 2022 dan Apotek Kimia Farma Galaxy Periode Maret 2022. Dengan dilaksanakannya Praktik Kerja Profesi Apoteker, calon Apoteker diharapkanmendapatkan pengalaman dan gambaran mengenai pekerjaan yang dilakukan oleh Apoteker di dunia kerja, khususnya di bidang industri farmasi dan apotek.

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The pharmacist profession has an important role in the pharmaceutical industry, hospitals, services, and government. A pharmacist candidate must carry out the Pharmacist Professional Practice in order to gain skills and experiences that needed to become a professional pharmacist in entering the world of work. This time, Pharmacist Professional Practices are carried out at PT. Takeda Indonesia for the period January – March 2022 and Kimia Farma Galaxy Pharmacy for the period March 2022. By implementing the Pharmacist Professional Practice, A pharmacist candidate is expected to gain experience and an overview of the work carried out by Pharmacists in the world of work, especially in the pharmaceutical and pharmacy industry."

"[ABSTRAKKegiatan PKP Praktek Kerja Profesi yang dilaksanakan di industri farmasi yaitu PT Kalbe Farma Tbk Cikarang bertujuan agar calon apoteker dapat memahami penerapan CPOB Cara Pembuatan Obat yang Baik di industri farmasi mengetahui secara garis besar gambaran pekerjaan kefarmasian di industri farmasi dan mendapatkan pengetahuan wawasan serta pengalaman praktis secara langsung dalam penerapan pekerjaan kefarmasian di industri farmasi Selama kegiatan PKP calon apoteker ditempatkan di bagian Pemastian Mutu sehingga memperoleh kesempatan untuk membuat protokol dan laporan validasi proses QA Matrix serta mengikuti pelatihan dan kegiatan induksi ke bagian lain seperti QC R D Logistik dan Teknik Adapun tugas khusus yang diberikan adalah Pembuatan Laporan Validasi Proses Tablet Asam Traneksamat yang merupakan validasi ulang karena adanya perubahan alat pada proses pencampuran dan perubahan jumlah sampel pada evaluasi kebocoran kemasan

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ABSTRACTThe aim of Professional Internship in the pharmaceutical industry namely PT Kalbe Farma Tbk Cikarang are to understand the application of GMP Good Manufacturing Practice in the pharmaceutical industry find out the general outline of the job in the pharmaceutical industry and gain knowledge insight and practical experience directly in the application of pharmaceutical jobs in the pharmaceutical industry During internship activities student was placed under Quality Assurance Section so that student got opportunities to create validation process protocol and report QA Matrix and also participate in training dan induction to the other section such as QC R D Logistic and Technical Section As for the special assignment was namely Validation Process Report of Tranexamic Acid Tablet which was revalidated because of equipment changing in mixing process and total sample changing in leakage test ;The aim of Professional Internship in the pharmaceutical industry namely PT Kalbe Farma Tbk Cikarang are to understand the application of GMP Good Manufacturing Practice in the pharmaceutical industry find out the general outline of the job in the pharmaceutical industry and gain knowledge insight and practical experience directly in the application of pharmaceutical jobs in the pharmaceutical industry During internship activities student was placed under Quality Assurance Section so that student got opportunities to create validation process protocol and report QA Matrix and also participate in training dan induction to the other section such as QC R D Logistic and Technical Section As for the special assignment was namely Validation Process Report of Tranexamic Acid Tablet which was revalidated because of equipment changing in mixing process and total sample changing in leakage test , The aim of Professional Internship in the pharmaceutical industry namely PT Kalbe Farma Tbk Cikarang are to understand the application of GMP Good Manufacturing Practice in the pharmaceutical industry find out the general outline of the job in the pharmaceutical industry and gain knowledge insight and practical experience directly in the application of pharmaceutical jobs in the pharmaceutical industry During internship activities student was placed under Quality Assurance Section so that student got opportunities to create validation process protocol and report QA Matrix and also participate in training dan induction to the other section such as QC R D Logistic and Technical Section As for the special assignment was namely Validation Process Report of Tranexamic Acid Tablet which was revalidated because of equipment changing in mixing process and total sample changing in leakage test ]"