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Hasil Pencarian

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Demetria Ulin Suci Aprilla
Abstrak :
ABSTRAK
Industri farmasi sebagai produsen produk obat memiliki peran besar dalam peningkatan upaya kesehatan yaitu melalui pengadaan obat-obatan. Industri farmasi memproduksi obat dengan berpedoman pada cara pembuatan obat yang baik (CPOB). Industri farmasi harus memiliki minimal tiga orang apoteker sebagai penanggungjawab masing-masing pada bidang pemastian mutu, produksi, dan pengawasan mutu. Tujuan praktik kerja profesi (PKP) ini supaya mahasiswa apoteker memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi dan paham penerapan CPOB. Mahasiswa apoteker di tempatkan di bagian quality assurance (QA) dan melakukan validasi metode pembersihan. Dari PKP yang dilakukan, mahasiswa PKP mendapat pengetahuan pekerjaan kefarmasian di industri farmasi, memperoleh keterampilan dalam melakukan validasi pembersihan alat, dan lebih memahami penerapan aspek-aspek CPOB di industri farmasi. ABSTRACT The pharmaceutical industry as a manufacturer of medicinal products have a major role in improving health efforts through drugs production. The pharmaceutical industry produces drugs by referring to good manufacturing product (GMP). The pharmaceutical industry must have at least three pharmacists as a responsible in quality assurance, production and quality control. The purpose of this internship programme are to get knowledge, skills, and practical experience in the pharmaceutical industry and to understand the application of GMP. Student was placed on the quality assurance (QA) and do cleaning validation. From the internship, students gain knowledge of pharmaceutical jobs in the pharmaceutical industry, acquire skills in performing cleaning validation tools, and better understand the application of aspects of GMP in the pharmaceutical industry.;The pharmaceutical industry as a manufacturer of medicinal products have a major role in improving health efforts through drugs production. The pharmaceutical industry produces drugs by referring to good manufacturing product (GMP). The pharmaceutical industry must have at least three pharmacists as a responsible in quality assurance, production and quality control. The purpose of this internship programme are to get knowledge, skills, and practical experience in the pharmaceutical industry and to understand the application of GMP. Student was placed on the quality assurance (QA) and do cleaning validation. From the internship, students gain knowledge of pharmaceutical jobs in the pharmaceutical industry, acquire skills in performing cleaning validation tools, and better understand the application of aspects of GMP in the pharmaceutical industry.;The pharmaceutical industry as a manufacturer of medicinal products have a major role in improving health efforts through drugs production. The pharmaceutical industry produces drugs by referring to good manufacturing product (GMP). The pharmaceutical industry must have at least three pharmacists as a responsible in quality assurance, production and quality control. The purpose of this internship programme are to get knowledge, skills, and practical experience in the pharmaceutical industry and to understand the application of GMP. Student was placed on the quality assurance (QA) and do cleaning validation. From the internship, students gain knowledge of pharmaceutical jobs in the pharmaceutical industry, acquire skills in performing cleaning validation tools, and better understand the application of aspects of GMP in the pharmaceutical industry.
Fakultas Farmasi Universitas Indonesia, 2016
PR-PDF
UI - Tugas Akhir  Universitas Indonesia Library
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Subhan Asfari
Abstrak :
ABSTRAK
Industri 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.
ABSTRACT
The 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.
Depok: Fakultas Farmasi Universitas Indonesia, 2017
PR-pdf
UI - Tugas Akhir  Universitas Indonesia Library
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Fitria Ramadhani
Abstrak :
ABSTRAK
Industri farmasi adalah badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat. Industri farmasi wajib memenuhi persyaratan Cara Pembuatan Obat yang Baik CPOB . Praktek Kerja Profesi PKP di PT. Medifarma Laboratories dilakukan pada tanggal 1 Februari ndash; 31 Maret 2017. Tujuan pelaksanaan PKP untuk memperoleh gambaran dan pengalaman mengenai peran profesi apoteker di industri farmasi, khususnya dalam bidang pemastian mutu. Kegiatan yang dilakukan selama PKP antara lain pengenalan secara umum mengenai PT. Medifarma Laboratories; induksi ke departemen yang berkaitan dengan pekerjaan kefarmasian yaitu Quality Assurance QA , Quality Control QC , Engineering, Production, Health Safety Environment HSE , Manufacturing Technology Unit MTU , logistic, dan membantu pekerjaan di Departemen QA seperti memeriksa dokumen untuk pelolosan produk jadi, dan membuat dokumen registrasi salah satu produk Medifarma. Medifarma Laboratories merupakan salah satu industri farmasi yang telah menerapkan pedoman CPOB dalam setiap kegiatan yang dilakukan, baik dalam proses produksi, pengawasan dan pemastian mutu, serta kegiatan lain yang terkait.
ABSTRACT
Pharmaceutical industry is a corporation that has a license from Minister of Health to manufacturing of drugs or drug materials. Pharmaceutical industry is obliged to comply with the requirements of Good Manufacturing Practice for Pharmaceuticals GMP . Profession internship at PT. Medifarma Laboratories held on February 1st to March 31st 2017. The aim of profession internship to obtain an overview and experience of professional role of pharmacists in pharmaceutical industry, particularly in a quality assurance. Activities conducted during profession internship among other general introduction about PT. Medifarma Laboratories induction into department which related pharmacy that are Quality Assurance QA , Quality Control QC , Engineering, Production, Health Safety Environment HSE , Manufacturing Technology Unit MTU , logistic and help the task at QA Department such as review document for finish good release and making dossier for registration one of product in PT.Medifarma Laboratories. PT. Medifarma Laboratories is the one of pharmaceutical industry which has implemented the GMP guidelines in each of activities, both in production process, control and quality assurance, and other related activities.
2017
PR-pdf
UI - Tugas Akhir  Universitas Indonesia Library
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Deni Lastanto
Abstrak :
ABSTRAK
Praktik kerja profesi di PT. Medifarma Laboratories Periode Bulan Agustus-September 2017 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;Value Stream Mapping Produk Jadi rdquo;. Tujuan dari tugas khusus ini adalah mengidentifikasi waste dan akar penyebab waktu tunggu proses pengiriman produk jadi dan penumpukan produk jadi di secondary packaging, staging area dan warehouse, serta mengusulkan ide continous improvement untuk mengurangi waktu tunggu dan penumpukan produk jadi di secondary packaging, staging area, dan warehouse.
ABSTRACT
Internship at PT. Medifarma Laboratories month period August-September 2017 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;Value Stream Mapping of Finished Goods rdquo;. The purpose of this special assignment is to identify waste and root cause of lead time of finished product delivery and accumulation of finished product in secondary packaging, staging area and warehouse, and propose continous improvement idea to reduce lead time and accumulation of finished product in secondary packaging, staging area and warehouse
2017
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UI - Tugas Akhir  Universitas Indonesia Library
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Annisa Rizky Shadrina
Abstrak :
Industri farmasi merupakan badan usaha yang melakukan kegiatan pembuatan obat atau bahan obat dan telah mendapatkan izin sesuai dengan ketentuan peraturan perundang-undangan. Industri farmasi dalam pembuatan obat memiliki pedoman CPOB (Cara Pembuatan Obat yang Baik) yang digunakan guna memastikan agar obat yang dihasilkan memiliki kualitas dan mutu yang sesuai dengan persyaratan serta tujuan penggunaannya. Dalam pedoman CPOB mencakup penjelasan mengenai sistem komputerisasi yang tertera pada aneks 7. Sistem komputerisasi terdiri dari sistem komputer dan fungsi atau proses yang dikendalikan. Salah satu sistem komputerisasi di PT. Medifarma Laboratories ialah Spreadsheet Laporan Kalibrasi Thermohygrometer. Dalam memastikan thermohygrometer tersebut memberikan hasil yang akurat, maka dilakukan kalibrasi. Laporan kalibrasi thermohygrometer disajikan dalam bentuk spreadsheet menggunakan aplikasi Microsoft Excel yang digunakan untuk perhitungan data hasil kalibrasi thermohygrometer. Sehingga, spreadsheet laporan kalibrasi thermohygrometer perlu dilakukan validasi untuk memastikan bahwa spreadsheet tersebut menghasilkan data yang akurat, konsisten, dan meminimalisir kesalahan dari perhitungan manual. Penelitian ini bertujuan untuk mengetahui proses penyusunan dokumen validasi sistem komputerisasi dan mengetahui hasil validasi sistem komputerisasi spreadsheet laporan kalibrasi thermohygrometer. Metode yang dilakukan dalam validasi sistem komputerisasi spreadsheet laporan kalibrasi thermohygrometer di PT. Medifarma Laboratories adalah membuat dokumen Computerised System Registration and Impact Assessment (CSRIA), User Requirement Specification (URS), Risk Assessment (RA), Validation Protocol (VP), dan Validation Report (VR). Hasil validasi spreadsheet laporan kalibrasi thermohygrometer di PT. Medifarma Laboratories sudah memenuhi kriteria dan spesifikasi yang dipersyaratkan oleh user (QA Supervisor) sehingga spreadsheet tersebut valid dan siap untuk digunakan. ......The pharmaceutical industry operates as a licensed entity engaged in manufacturing drugs or medicinal components in accordance with legal regulations. This sector adheres to GMP (Good Manufacturing Practices) guidelines to ensure the production of drugs that meet quality standards and intended purposes. The CPOB guidelines encapsulate computerized systems, including a Thermohygrometer Calibration Report Spreadsheet used at PT. Medifarma Laboratories. Calibration ensures accurate thermohygrometer results, and this calibration report is presented using Microsoft Excel, facilitating calculation of calibration data. Validation of the thermohygrometer calibration report spreadsheet is crucial to ensure accuracy, consistency, and minimize manual calculation errors. This study focuses on the process of compiling validation documents for the computerized system and evaluating the validation results of the thermohygrometer calibration report spreadsheet. The validation process at PT. Medifarma Laboratories involves creating Computerized System Registration and Impact Assessment (CSRIA) documents, User Requirement Specification (URS), Risk Assessment (RA), Validation Protocol (VP), and Validation Report (VR). The validation of the thermohygrometer calibration report spreadsheet at PT. Medifarma Laboratories confirms its adherence to user (QA Supervisor) criteria and specifications, establishing its validity and readiness for use. This validation process guarantees accurate and reliable data, enhancing the quality and reliability of thermohygrometer calibration reporting within the pharmaceutical manufacturing context. The integration of computerized system validation ensures the precision and integrity of crucial processes in the pharmaceutical industry.
Depok: Fakultas Farmasi Universitas Indonesia, 2023
PR-pdf
UI - Tugas Akhir  Universitas Indonesia Library