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Abstrak :
CPOB merupakan pedoman yang bertujuan untuk memastikan agar mutu obat yang dihasilkan sesuai persyaratan dan tujuan penggunannya, bila perlu dapat dilakukan penyesuaian pedoman dengan syarat bahwa standar mutu obat yang telah ditentukan tetap dicapai. Salah satu aspek pada Sistem Pemastian Mutu yang harus benar dan tepat dalam pembuatan obat adalah memastikan pemasok bahan awal dan bahan pengemas dievaluasi dan disetujui untuk memenuhi spesifikasi mutu yang telah ditentukan oleh perusahaan. Tugas khusus ini bertujuan untuk melakukan kesesuaian data pada manajemen vendor yang berupa monitoring vendor dan kualifikasi vendor serta mengembangkan sistem mapping agar pengolahan data tersebut lebih efisien. Pengambilan data diperoleh dengan observasi dan studi literatur untuk mengetahui metode yang efektif dalam melakukan mapping dan kesesuaian data untuk dikembangkan pada sistem data manajemen vendor yang telah ada. Berdasarkan hasil observasi dan studi literatur, dapat disimpulkan bahwa monitoring vendor dan kualifikasi vendor telah dilakukan pengembangan sistem pendataan. ......GMP is a guideline that aims to ensure that the quality of the drugs produced is in accordance with the requirements and intended use. If necessary, adjustments to the guidelines can be made on the condition that the predetermined drug quality standards are still achieved. One of the aspects of the Quality Assurance System that must be correct and precise in the manufacture of drugs is ensuring that suppliers of starting materials and packaging materials are evaluated and approved to meet the quality specifications set by the company. This special task aims to conform data to vendor management in the form of monitoring vendors and vendor qualifications as well as developing a mapping system so that data processing is more efficient. Data collection was obtained by observation and literature study to find out effective methods for mapping and suitability of data to be developed in existing vendor management data systems. Based on the results of observations and literature studies, it can be concluded that vendor monitoring and vendor qualifications have been carried out by developing a data collection system.

Abstrak :
Rendah nya nilai OEE mesin kemas strip terhadap produk X di PT. Soho Industri Pharmasi, merupakan salah satu permasalahan yang berhubungan dengan kemampuan mesin dalam mencapai output yang telah ditetapkan. Nilai OEE produk X rendah disebabkan oleh banyak faktor salah satunya issue change parts produk. Desain penelitian yang digunakan dalam pelaksanaan tugas khusus ini menggunakan desain studi kasus (case study). Sampel diambil dengan cara pengamatan di mesin strip untuk mengetahui change parts bermasalah. Data yang diambil berupah change parts yang menyebabkan mesin berhenti untuk memperbaiki change parts yang bermasalah. Evaluasi sampel dilakukan dengan mendata masalah change parts yang menyebabkan OEE produk rendah dan solusi terhadap masalah change parts produk. Nilai OEE produk X dibawah 51 %. Masalah sleading feeding chute dan feeding per produk X menyebabkan nilai OEE satu batch pada pengamatan pertama sebesar 29% dan pengamatan kedua sebesar 48%. Modifikasi ulang part tambahan feeding chute dan feeding per menyebabkan lost time pada saat pengemasan yang mempengaruhi OEE produk X. ......The low OEE value of the strip packaging machine for product X at PT. Soho Industrial Pharmacy, is one of the problems related to the machine's ability to achieve the specified output. The low OEE value of product X is caused by many factors, one of which is the issue of changing product parts. The research design used in carrying out this special assignment uses a case study design. Samples are taken by observing the strip machine to find out problematic change parts. The data taken is in the form of change parts which causes the machine to stop to repair problematic change parts. Sample evaluation is carried out by recording change parts problems that cause low product OEE and solutions to product change parts problems. The OEE value of product X is below 51%. The problem of sleading feeding chute and feeding per product Re-modifying the additional parts of the feeding chute and feeding spring causes lost time during packaging which affects the OEE of product X.

Abstrak :
Proses pengemasan merupakan salah satu bagian penting dalam produksi sediaan farmasi. Proses pengemasan adalah proses dimana obat dikemas ke dalam pengemas yang kompatibel sehingga menjadi produk jadi. Proses pengemasan produk, khususnya liquid terdiri dari proses pengemasan primer, sekunder, dan tersier. Dimana proses ini diharapkan berlangsung cepat untuk mendapatkan output sesuai dengan target. Namun, adanya loss time pada proses pengemasan akan mengakibatkan output yang diperoleh akan berkurang, selain itu waktu yang diperlukan untuk tahap pengemasan juga akan menjadi lebih lama. Loss time adalah waktu yang hilang dan yang tidak dapat dipergunakan untuk memberikan nilai tambah pada suatu produk. Penelitian ini bertujuan untuk mengetahui penyebab terjadinya Loss time serta improvement dalam mengatasi permasalahan pada pengemasaan sediaan liquid. Pelaksanaan perbandingan kesesuaian dilakukan berdasarkan studi observasi pada grey area pengemasan primer dan sekunder sediaan liquid. Hasil yang didapatkan terkait penyebab Loss time pada PT. Soho Industri Pharmasi secara garis besar ada 3, yaitu yang pertama planned stoppages berupa waktu istirahat yang lebih dari 30 menit dan pergantian shift. Kemudian yang kedua unplanned stoppages, terkait permasalahan pada flap box depan terbuka. Sedangkan kejadian yang menyebabkan loss time terakhir adalah unexplained stoppages, berupa kendala pada jembatan penghubung yang tidak rata dan lengket. ...... The packaging process is an important part in the production of pharmaceutical preparations. The packaging process is a process where drugs are packaged into compatible packaging so that they become finished products. The product packaging process, especially liquids, consists of primary, secondary and tertiary packaging processes. Where this process is expected to take place quickly to get output according to the target. However, the presence of loss time in the packaging process will result in the output obtained being reduced, besides that the time required for the packaging stage will also be longer. Loss time is time that is lost and cannot be used to provide added value to a product. This research aims to determine the causes of loss time and improvements in overcoming problems in the packaging of liquid preparations. The conformity comparison was carried out based on observational studies in the gray area of primary and secondary packaging of liquid preparations. The results obtained are related to the causes of loss time at PT. In general, there are 3 Soho Industrial Pharmacies, namely the first is planned stoppages in the form of rest periods of more than 30 minutes and shift changes. Then the second is unplanned stoppages, related to problems with the front flap box opening. Meanwhile, the incident that caused the latest loss time was unexplained stoppages, in the form of obstacles on the connecting bridge that were uneven and sticky.

Abstrak :
Compatibility of pharmaceutical products and contact materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe : - Pertinent regulations and practical ways to meet guidelines - Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development - Materials characterization and the materials screening process - Component and/or system qualification (illustrated by several case studies) - Performing validation/migration studies and interpreting and reporting the results - Creating a product registration dossier and putting it through regulatory review - Product maintenance (Change Control) from an extractables and leachables perspective - Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature.