Ditemukan 6 dokumen yang sesuai dengan query
Universitas Indonesia, 2010
TA4357
UI - Tugas Akhir Universitas Indonesia Library
Nur Isra
"
ABSTRAKPraktek Kerja Profesi Apoteker di PT Aventis Pharma. bertujuan agar mahasiswa dapat memahami peran tugas, dan tanggung jawab apoteker di industri farmasi, yaitu sebagai peran kunci dalam pemastian mutu, pengawasan mutu, dan produksi di industri farmasi. Tugas khusus yang diberikan dengan judul kualifikasi HPLC yang bertujuan untuk mengetahui apakah prosedur kualifikasi HPLC yang dilakukan telah sesuai dengan CPOB
ABSTRACTApothecary Profession Internship at PT Aventis Pharma aiming for students to understand the role of the task, and the responsibility of pharmacists in the pharmaceutical industry, namely as a key role in quality assurance, quality control, and production in the pharmaceutical industry. Specific assignments are given by title HPLC qualification which aimed to determine whether the HPLC qualification procedures performed were in accordance with CPOB."
2019
PR-pdf
UI - Tugas Akhir Universitas Indonesia Library
Marianne Wiguna
"[
ABSTRAK Industri farmasi merupakan badan usaha yang memiliki izin dari Kementerian Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat Dalam pembuatan obat tersebut terdapat suatu Cara Pembuatan Obat yang Baik CPOB Apoteker bertanggung jawab dalam pelaksanaan pekerjaan kefarmasian dalam hal pembuatan obat Peranan penting Apoteker di industri farmasi yaitu bertanggung jawab dalam produksi pengawasan mutu dan pemastian mutu produk yang dibuat dalam industri farmasi Permasalahan kefarmasian yang dapat terjadi adalah pada proses produksi adanya keluhan pelanggan maupun adanya target hasil yang harus dicapai dalam jangka waktu yang singkat
ABSTRACT Pharmaceutical industry is a business entity which has permission from Ministry of Health to produce drug or drug raw material In the drug production there is a Good Manufacturing Product GMP Pharmacist has responsibility in the implementation of pharmacy jobs especially in drug production The important roles of pharmacist in pharmaceutical industry are having responsibility for drug production quality control and quality assurance The pharmaceutical problems which can be occurred are in the drug production customer complaint and the target to be achieved in the short period of time ;Pharmaceutical industry is a business entity which has permission from Ministry of Health to produce drug or drug raw material In the drug production there is a Good Manufacturing Product GMP Pharmacist has responsibility in the implementation of pharmacy jobs especially in drug production The important roles of pharmacist in pharmaceutical industry are having responsibility for drug production quality control and quality assurance The pharmaceutical problems which can be occurred are in the drug production customer complaint and the target to be achieved in the short period of time ;Pharmaceutical industry is a business entity which has permission from Ministry of Health to produce drug or drug raw material In the drug production there is a Good Manufacturing Product GMP Pharmacist has responsibility in the implementation of pharmacy jobs especially in drug production The important roles of pharmacist in pharmaceutical industry are having responsibility for drug production quality control and quality assurance The pharmaceutical problems which can be occurred are in the drug production customer complaint and the target to be achieved in the short period of time , Pharmaceutical industry is a business entity which has permission from Ministry of Health to produce drug or drug raw material In the drug production there is a Good Manufacturing Product GMP Pharmacist has responsibility in the implementation of pharmacy jobs especially in drug production The important roles of pharmacist in pharmaceutical industry are having responsibility for drug production quality control and quality assurance The pharmaceutical problems which can be occurred are in the drug production customer complaint and the target to be achieved in the short period of time ]"
Depok: Fakultas Farmasi Universitas Indonesia, 2015
PR-Pdf
UI - Tugas Akhir Universitas Indonesia Library
Rosita Kurniawan
"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 yang diatur dalam CPOB. Apoteker berperan sebagai personil kunci dalam industri farmasi yaitu sebagai kepala bagian produksi, kepala bagian pemastian mutu, dan kepala bagian pengawasan mutu. Praktik kerja profesi yang dilaksanakan di PT Mahakam Beta Farma dilaksanakan untuk membantu calon apoteker mendapat pengetahuan serta pengalaman praktik di industri farmasi. Pada praktik kerja ini juga dilakukan pelaksanaan tugas khusus yaitu pembuatan Pengkajian Mutu Produk PMP . Pembuatan PQR dilakukan dengan tujuan untuk melihat tren data dalam suatu periode, mengidentifikasi perbaikan yang diperlukan untuk produk serta membuktikan konsistensi proses, kesesuaian dari spesifikasi bahan awal, bahan pengemas, dan obat jadi.
Pharmaceutical industry is a business entity that has permission to perform activities of making drugs or medicinal materials. To ensure the quality of the drugs produced, the pharmaceutical industry is obliged to apply Good Manufacturing Practice GMP . Pharmacists are one of the important aspects regulated in the GMP. Pharmacists serve as key personnel in the pharmaceutical industry as head of production, head of quality assurance, and head of quality control. The internship at PT Mahakam Beta Farma are conducted to help prospective pharmacists gain knowledge and experience in the pharmaceutical industry. This internship also carried out specific assignment, making Product Quality Review PQR . PQR is performed in order to look at data trends over a period, identify the necessary improvements to the product as well as prove the consistency of the process, the suitability of the specification of starting materials, packing materials and finished drugs. "
Depok: Fakultas Farmasi Universitas Indonesia, 2017
PR-Pdf
UI - Tugas Akhir Universitas Indonesia Library
Fatmawati Fadlin
Depok: Fakultas Farmasi Universitas Indonesia, 2018
PR-Pdf
UI - Tugas Akhir Universitas Indonesia Library
Reza Adhitya Pratama
"Dalam proses produksi suatu obat, sangat penting untuk menjaga konsistensi kualitasnya agar hak konsumen dalam mendapatkan produk yang baik dapat terjamin. Pemastian mutu merupakan salah satu cara yang tercantum dalam CPOB untuk menjaga konsistensi kualitas suatu obat. Salah satu cakupan pemastian mutu adalah pengendalian mutu produk dan salah satu contoh pengendalian mutu produk adalah mengendalikan temperatur, kelembaban, dan tekanan udara pada ruangan produksi obat. Dalam proses produksi obat, ini merupakan hal yang patut diperhatikan sebab akan mempengaruhi kualitas obat yang dihasilkan. Studi ini bertujuan untuk mengetahui alasan dilakukannya kajian monitoring temperatur, kelembaban, dan tekanan udara pada ruang produksi obat sekaligus melihatnya apakah sudah sesuai yang dipersyaratkan atau tidak, dan jika tidak sesuai maka mengetahui kemungkinan penyebab dan tindakan perbaikan termasuk pengaruh yang akan terjadi pada produk yang sedang diproses. Dari hasil pengamatan, diketahui bahwa kajian monitoring dilakukan untuk memastikan agar kualitas obat yang dihasilkan memenuhi persyaratan serta untuk melihat kembali apakah keadaan ruangan produksi selama 1 tahun kebelakang tetap sesuai yang dipersyaratkan. Secara umum temperatur, kelembaban, dan tekanan udara di area produksi PT. Sydna Farma memenuhi persyaratan internal yang ditetapkan. Salah satu tindakan perbaikan yang dapat dilakukan adalah menyiapkan temperatur, kelembaban, dan tekanan udara sesuai persyaratan sebelum digunakan untuk proses produksi dan salah satu penyebab ruangan produksi tidak memenuhi persyaratan adalah ruangan tersebut baru selesai dibersihkan.
In the process of drug production, it's especially important to maintain consistency of quality so that consumers' rights to obtain a good product can be guaranteed. Quality assurance is one of the ways listed in GMP to maintain the quality of a drug. Part of quality assurance is product quality control, and the example of product quality control is controlling temperature (T), relative humidity (RH), and air pressure (P) in drug production rooms. This should be considered because it will affect the quality of the drug produced. This study aims to find out the reason for carrying out a study of monitoring T, RH, and P in the drug production room as well as to see whether it's exactly like the requirements or not, and if it's not same then find out the potential causes and corrective actions including the effects that will occur on the drug being processed. From the observations, it's known that monitoring studies are carried out to ensure the quality of the drugs produced meets the requirements and to review whether the condition of the production room for the past 1 year has remained as required. In general, T, RH, and P in the production area are like the specified internal requirements. One of the corrective actions that can be taken is to prepare the T, RH, and P correctly like requirements before being used and one of the causes of the production room not meeting the requirements is because the room has just been cleaned."
Depok:
2022
PR-pdf
UI - Tugas Akhir Universitas Indonesia Library
