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"Pengukuran kadar air dalam bahan pangan dapat ditentukan dengan beberapa metode yaitu dengan metode pengeringan (thermogravimetri), metode destilasi (thermovolumetri), metode fisis dan metode kimiawi menggunakan Karl Fischer. Metode Karl Fischer memerlukan pembakuan larutan atau standarisasi larutan yang bertujuan untuk mengetahui konsentrasi larutan secara pasti yang akan digunakan untuk analisis volumetri. Sodium Tartrate Dihydrate Water Standard Ex. Merck dapat menjadi pilihan sebagai pembaku atau standar dalam titrasi Karl Fischer. Oleh karena itu, dilakukan studi diversifikasi reagen standard yang bertujuan untuk membandingkan pembakuan Karl Fischer menggunakan reagen HYDRANAL™ - Water Standard 10.0 Ex. Fluca Analytical (eksisting) dengan Sodium Tartrate Dihydrate Water Standard Ex. Merck terhadap hasil pembakuan Karl Fischer. Prosedur yang dilakukan adalah membandingkan Metode 1 menggunakan Reagen HYDRANAL™ - Water Standard 10.0 dengan Metode 1 menggunakan Reagen Sodium Tartrate Dihydrate Water Standard. Hasil yang didapatkan yaitu Metode 2 (SODIUM TARTRATE DIHYDRATE WATER STANDARD) lebih mendekati syarat untuk hasil pembakuan serta memiliki nilai RSD hasil pembakuan dan analisis % kadar air sesuai yang dipersyaratkan untuk Hydranal Titrant Composite 5. Sedangkan untuk Hydranal Titrant 5 didapatkan bahwa pembakuan menggunakan Metode 1 (Reagen HYDRANAL™ - Water Standard 10.0) dan Metode 2 (SODIUM TARTRATE DIHYDRATE WATER STANDARD) adalah setara namun untuk perhitungan % kadar air didapatkan Metode 2 (SODIUM TARTRATE DIHYDRATE WATER STANDARD) lebih memenuhi syarat dibandingkan dengan Metode 1 (Reagen HYDRANAL™ - Water Standard 10.0)

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Measuring the water content in food can be determined by several methods, namely the drying method (thermogravimetry), the distillation method (thermovolumetry), the physical method, and the chemical method using Karl Fischer. The Karl Fischer method requires standardization of the solution or standardization of the solution which aims to determine the exact concentration of the solution to be used for volumetric analysis. Sodium Tartrate Dihydrate Water Standard Ex. Merck can be an option as a standard or standard in Karl Fischer titrations. Therefore, a standard reagent diversification study was carried out which aimed to compare the standardization of Karl Fischer using the HYDRANAL™ - Water Standard 10.0 Ex reagent. Fluca Analytical (existing) with Sodium Tartrate Dihydrate Water Standard Ex. Merck to standardization results of Karl Fischer. The procedure performed was to compare Method 1 using HYDRANAL™ - Water Standard 10.0 Reagent with Method 1 using Sodium Tartrate Dihydrate Water Standard Reagent. The results obtained are Method 2 (SODIUM TARTRATE DIHYDRATE WATER STANDARD) which is closer to the requirements for standardization results and has an RSD value resulting from standardization and analysis of % water content as required for Hydranal Titrant Composite 5. Meanwhile, for Hydranal Titrant 5 it was found that standardization used Method 1 (HYDRANAL™ Reagent - Water Standard 10.0) and Method 2 (SODIUM TARTRATE DIHYDRATE WATER STANDARD) are equivalent but for the calculation of % water content, Method 2 (SODIUM TARTRATE DIHYDRATE WATER STANDARD) is more qualified than Method 1 (Reagent HYDRANAL™ - Water Standard 10.0)."

"Apoteker merupakan salah satu profesi penting dalam pelayanan kesehatan yang berfokus pada pelayanan kefarmasian, yaitu pelayanan langsung dan bertanggung jawab kepada pasien terkait dengan sediaan farmasi dengan tujuan untuk meningkatkan mutu kehidupan pasien. Sebelum memasuki dunia kerja sesungguhnya, calon apoteker dituntut untuk menjalani Praktik Kerja Profesi Apoteker (PKPA) sebagai gambaran nyata tentang pekerjaan kefarmasian. PKPA merupakan suatu sarana pembelajaran bagi calon apoteker untuk meningkatkan pemahamannya mengenai peran, fungsi, dan tanggung jawabnya di fasilitas kefarmasian yang sesuai. Kegiatan PKPA dilaksanakan di dua tempat, yaitu di PT Kalbe Farma Tbk pada periode Januari – Februari 2022 dan di Apotek Roxy Keamanan pada periode April 2022. Dengan adanya kegiatan PKPA ini, calon apoteker diharapkan memiliki wawasan, pengetahuan, dan keterampilan untuk memahami tugas dan tanggung jawabnya dalam menajalankan pekerjaan kefarmasian di Apotek dan Industri Farmasi. Selain itu, diharapkan pula dapat meningkatkan rasa percaya dirinya untuk menjadi Apoteker yang profesional.

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Pharmacist are one of the important professions in health services that focus on pharmaceutical services, which is direct services and responsible to patients related to pharmaceutical preparations with the aim of improving the patient’s quality of life. Before entering the real world of work, aspiring pharmacist are required to undergo the Pharmacist Professional Work Practice (PKPA) as a real picture of pharmaceutical work. PKPA is a learning tool for aspiring pharmacist to improve their understanding of their roles, functions, and responsibilities in appropriate pharmaceutical facilities. PKPA are carried out in two places, at PT Kalbe Farma Tbk in the January – February 2022 period and at Apotek Roxy Keamanan in the April 2022 period. With this PKPA activity, aspiring pharmacist are expected to have insight, knowledge, and skills to understand their duties and responsibilities in carrying out pharmaceutical work in the Pharmacy and Pharmaceutical Industry. In addition, it’s also expected to increase their confidence to become a professional pharmacist."

"Apoteker memegang peran penting dalam fasilitas kefarmasian seperti Industri Farmasi, Pedagang Besar Farmasi, dan Apotek. Apoteker perlu memastikan dan menjaga mutu, keamanan, serta khasiat obat mulai dari proses produksi obat, distribusi obat, sampai obat diterima oleh pasien. Maka dari itu, apoteker harus memiliki kompetensi yang baik sesuai dengan Standar Kompetensi Apoteker. Praktik Kerja Profesi Apoteker merupakan salah satu persyaratan yang harus dipenuhi agar apoteker dapat mengetahui perannya dan meningkatkan kompetensinya. Praktik Kerja Profesi Apoteker dilaksanakan di PT Kalbe Farma Tbk pada periode 3 Januari-25 Februari 2022, Apotek Roxy Telajung pada periode 2-26 Maret 2022, dan PT Anugerah Pharmindo Lestari pada periode 1-14 April 2022. Praktik Kerja Profesi Apoteker ini diharapkan dapat membantu apoteker dalam mengembangkan kemampuannya dan memperoleh pengetahuan baru terkait profesinya di Industri Farmasi, Pedagang Besar Farmasi, dan Apotek.

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Pharmacists play a vital role in pharmaceutical facilities, such as pharmaceutical industry, pharmaceutical distributor, and pharmacy. Pharmacists need to ensure and maintain the quality, safety, and the efficacy of drugs starting from the drug production process, drug distribution, until drugs are received by patients. Therefore, pharmacists are required to have good competencies in accordance with the pharmacist competency standards. The Professional Practices of Pharmacist is one of the requirements that have to be carried out so that prospective pharmacists can understand their role and improve their competencies. The Professional Practices of Pharmacist are carried out at PT Kalbe Farma Tbk for the period 3 January-25 February 2022, Apotek Roxy Telajung for the period 2-26 March 2022, and PT Anugerah Pharmindo Lestari for the period 1-14 April 2022. The Professional Practices of Pharmacist is expected to help pharmacists in expanding their skills and gaining new knowledge related to their profession in pharmaceutical industry, pharmaceutical distributor, and pharmacy."

"Apoteker berperan penting dalam pelaksanaan pekerjaan kefarmasian yang bertujuan untuk melindungi pasien dan masyarakat, meningkatkan mutu pekerjaan kefarmasian, serta memberikan kepastian hukum bagi pasien, masyarakat, dan tenaga kefarmasian. Untuk melaksanakan pekerjaan kefarmasian yang memenuhi standar, calon apoteker perlu melakukan praktik kefarmasian melalui praktik kerja profesi. Praktik kerja profesi apoteker diharapkan dapat membimbing calon apoteker dalam memahami peran dan kompetensi apoteker dalam berbagai bidang. Praktik Kerja Profesi Apoteker dilaksanakan di PT Kalbe Farma Tbk (Periode Januari - Februari 2022) sebagai praktik pada bidang industri; Badan Pengawas Obat dan Makanan (Periode Maret 2022) sebagai praktik pada bidang pemerintahan; dan Apotek Roxy Keamanan (Periode April 2022) sebagai praktik pada bidang komunitas. Berdasarkan hasil praktik profesi yang dilakukan, calon apoteker diharapkan dapat memperluas pengetahuan dan keterampilan untuk dapat melakukan pekerjaan kefarmasian.

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Pharmacists play an important role in the implementation of pharmaceutical work that aims to protect patients and the community, improve the quality of pharmaceutical work, and provide legal certainty for patients, the community, and pharmaceutical staff. To carry out pharmaceutical work that meets standards, prospective pharmacists need to practice pharmacy through professional work practices. Pharmacist Professional Practice is expected to guide prospective pharmacists in understanding the role and competence of pharmacists in various fields. Pharmacist Professional Practice is held at PT Kalbe Farma Tbk (January - February 2022) as a practice in the industrial sector; National Agency of Drug and Food Control (March 2022 Period) as a practice in government field; and Apotek Roxy Keamanan (April 2022 Period) as a community practice. Based on the results of professional practice carried out, prospective pharmacists are expected to expand their knowledge and skills to be able to do pharmaceutical work."

"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."

"Apoteker merupakan personil kunci dalam suatu industri farmasi dan berperan penting dalam menjaga mutu dan keamanan obat yang dihasilkan. Untuk itu, apoteker perlu untuk mengetahui tugas dan tanggung jawab apoteker di industri farmasi dan memahami penerapan Cara Pembuatan Obat yang Baik CPOB di Industi Farmasi, memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi dimana hal-hal ini dicapai melalui praktik kerja profesi di PT Kalbe Farma, Tbk. Dalam praktik kerja profesi ini juga dilakukan analisa untuk meningkatkan Batch Right First Time BRFT dalam rangka usaha untuk menurunkan lead time pelulusan produk Toll-Out PT Kalbe Farma, Tbk. dengan PT X yang dibahas dalam tugas khusus. Solusi yang menjadi hasil dari tugas khusus ini berupa perubahan format PPI, namun hasil dari implementasinya belum dapat teramati.

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Pharmacists is a key person in pharmacy industry and play an important role at ensure the quality and safety of the drug. There for, future pharmacists need to understand the duties and responsibilities of pharmacists in the pharmaceutical industry the application of good manufacturing practice GMP in the pharmaceutical industry, have the insight, knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry which can be reached by internship at PT Kalbe Farma, Tbk. During this internship, the writer conducts analysis to increase Batch Right First Time BRFT in order to decrease lead time of releasing Toll-Out products of PT Kalbe Farma, Tbk with PT X which discussed in special assignment report. The solution as the conclusion of this assignment was a change to production procedure master, but the result of the implementation can rsquo;t be observed yet."

"[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 ]"

"Industri farmasi merupakan badan usaha yang memiliki izin untuk melakukan kegiatan pembuatan obat atau bahan obat. Untuk menjamin mutu obat yang dihasilkan, industri farmasi wajib menerapkan Cara Pembuatan Obat yang Baik CPOB . Apoteker merupakan salah satu aspek penting dalam CPOB, yaitu sebagai personil kunci dalam produksi, pengawasan mutu, dan pemastian mutu. Praktik kerja profesi di PT Kalbe Farma, Tbk. bertujuan untuk mengetahui tugas dan tanggung jawab apoteker di industri farmasi dan memahami penerapan 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. Pada praktik kerja juga dilakukan tugas khusus mengenai pembuatan Master Production Document MPD Tablet M. MPD dibuat untuk menyempurnakan aspek dokumentasi dan mempermudah pencarian data lengkap ketika dibutuhkan sehingga meningkatkan efektivitas waktu penelusuran. Dari praktik kerja profesi di PT Kalbe Farma, Tbk., calon apoteker telah mendapatkan kemampuan untuk memahami peran, tugas, wawasan dan tanggung jawab apoteker dan memberikan solusi pada permasalahan di industri farmasi.

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Pharmaceutical industry is a business entity that has permission to make drugs or drug raw materials. To ensure the quality of the drugs, a pharmaceutical industry is obliged to perform Good Manufacturing Practice GMP . Pharmacist is one of the important aspects in GMP, as key personnel in production, quality assurance, and quality control. Internship at PT Kalbe Farma, Tbk. was held to help prospective pharmacists in understanding responsibilities of pharmacists and application of GMP in the pharmaceutical industry. In addition, the prospective pharmacists were expected to gain insight, knowledge, skills and practical experience in undertaking pharmaceutical works in the pharmaceutical industry. The internship also carried out special assignment about making of Master Production Document MPD Tablet M. MPD is made to improve documentation, thus it will make complete data searching easier when it is needed and increase effectiveness of searching time. After internship in PT Kalbe Farma, Tbk., prospective pharmacist is able to understand duties and responsibilities of pharmacists and provide solution to problems in pharmaceutical industry."

"Praktek kerja profesi PKPA di PT Kalbe Farma, Tbk. periode Maret - April 2018 bertujuan untuk mengetahui tugas dan tanggung jawab Apoteker di Industri Farmasi, memiliki wawasan dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi, memahami penerapan GMP CPOB , serta memiliki gambaran nyata mengenai permasalahan pekerjaan kefarmasian di Industri Farmasi. Dalam proses pembuatan obat, obat hanya boleh diproduksi oleh Industri Farmasi yang menerapkan 12 aspek CPOB yang ditandai dengan sertifikat CPOB. Selama menjalani PKPA, penulis membandingkan penerapan CPOB dan melakukan kegiatan di departemen Quality Control. Adapun tugas khusus yang diberikan terkait dengan pemenuhan standar WHO, berupa perbaikan Standar Prosedur Operasional, Metode Analisis, dan Spesifikasi, serta pembuatan Lembar Kerja Analisis. Secara umum, PTKalbe Farmatelah 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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Study Apprenticeship PKPA in PT Kalbe Farma, Tbk. March - April 2018 Period aims to understand the duties and responsibilities of Pharmacists in Pharmaceutical Industries, gain the insight, knowledge, skills and field experience to undertake pharmaceutical practice in Pharmaceutical Industries, understand the implementation of GMP CPOB , and have a real experience related to challenges in pharmaceutical practices in Pharmaceutical Industries. Within drugs production, only a certified Pharmaceutical Industry can conduct such process, marked with the implementation of the 12 aspects of GMP through its certification. While doing the apprenticeship, author conducted a gap analysis of GMP implementation as well as worked in Quality Control department. Another assignment given was related to WHO standard compliances regarding Standard Operating Porcedure, Analysis Method, and Specification, and Analytical Worksheet. In general, PT Kalbe Farma, Tbk. has implemented the 12 aspects of GMP well. In addition, author also understood the roles, duties, insights and responsibilities of Pharmacists, as well as provided solutions for problems or challenges encountered within the Pharmaceutical Industry."

"Industri farmasi dalam melakukan seluruh aktivitas pembuatan obat atau bahan obat wajib menerapkan pedoman terbaru Cara Pembuatan Obat yang Baik (CPOB). CPOB juga menyatakan bahwa apoteker merupakan personil kunci di industri farmasi yakni sebagai kepala bagian produksi, kepala bagian pengawasan mutu, dan kepala pengawasan mutu. Apoteker dituntut memiliki pengetahuan, keterampilan, dan pengalaman praktis dalam menerapkan CPOB di industri farmasi. Oleh karena itu, PT. Kalbe Farma, Tbk. memberikan kesempatan kepada calon apoteker untuk dapat melaksanakan praktik kerja profesi apoteker sehingga membantu calon apoteker dalam berpraktik di dunia industri farmasi pada masa mendatang.

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In conducting all of drug manufacturing activities, pharmaceutical industries are required to apply the latest guideline of Good Manufacturing Practice (GMP). GMP states that pharmacists are the key pesonnel in pharmaceutical industry as head of production, head of quality control, and head of quality assurance . Pharmacist are required to have knowledge, skills, and experience in applying GMP in pharmaceutical industry. Therefore, PT Kalbe Farma Tbk. provides the opportunity for apothecary student to have practical experience in pharmaceutical industry for the future."