CPOB Sediaan Steril
DOI:
https://doi.org/10.57213/caloryjournal.v2i4.507Keywords:
CPOB, Medical Product, Sterile Drugs, Infusions, InjectionsAbstract
The importance of Good Manufacturing Practices (GMP) in the pharmaceutical industry to ensure the quality and safety of drug products. GMP aims to ensure that all pharmaceutical preparations, including sterile drugs such as infusions and injections, meet strict quality standards. Sterility testing is an important aspect even though it has limitations, such as long incubation times and low probability of detecting contamination. Therefore, any sterility test results that do not meet the requirements must be further investigated to find the cause, either from laboratory errors or contamination in the production process. In addition, the implementation of technical and managerial aspects in accordance with GMP, such as temperature and humidity control, is very important to maintain product quality. This article also highlights the use of modern technologies, such as Service Oriented Architecture (SOA), to improve efficiency and transparency in the drug production process, so that it can meet all the provisions set.
References
Khalifa, A. A. M., & Prawiroredjo, K. (2022). Model Sistem Pengendalian Suhu dan Kelembaban Ruangan Produksi Obat Berbasis NodeMCU ESP32. Jurnal ELTIKOM, 6(1), 13–25. https://doi.org/10.31961/eltikom.v6i1.415
Makky, M. A., & Yasirandi, R. (2021). Perancangan Model Service Oriented Architecture Pada Proses the Model of Service Oriented Architecture for Drug Production Process Based on Good Manufacturing Practice ( Gmp ) Document. JIKO (Jurnal Informatika Dan Komputer), 4(1), 60–67. https://doi.org/10.33387/jiko
N, L. (2010). Kajian Pengendalian Sterilitas Pada Pembuatan Senyawa Bertanda. Seminar Nasional Kimia Dan Pendidikan Kimia IX (SN-KPK IX), 1(1), 238–245.
PTRR, P. (2018). Penentuan Penempatan Sensor Particle Counter Pada Clean Room Produksi Kit Radiofarmaka. Seminar Nasional Xi Sdm Teknologi …, 7–14. http://reponkm.batan.go.id/id/eprint/7403%0Ahttp://reponkm.batan.go.id/7403/1/Prosiding SDMTN 2018.pdf
Putra, A. R., Maskur, Lestari, E., Suharmadi, Gunawan, A. H., & Awaludin, R. (2017). Pemantauan Cemaran Partikel dan Mikrobiologi Lingkungan Clean Room untuk Proses Produksi Kit Radiofarmasi. Seminar Pendayagunaan Teknologi Nuklir, 8(November), 21–23.
Rini, A. C. (2014). Penerapan Cara Pembuatan Obat yang Baik (CPOB) di Industri Farmasi PT. Combiphar, Padalarang.
Setiawati, H., & Lolo Lukita, B. (2022). Review: Uji Sterilitas dan Regionalisasi Laboratorium Sterilitas Badan POM. Eruditio : Indonesia Journal of Food and Drug Safety, 2(1), 36–46. https://doi.org/10.54384/eruditio.v2i1.96
Sukmayadi, A. E., Hayati, Y., & Rahmah, A. N. (2023). Uji Cemaran Mikroba Udara Pada Beberapa Ruang Produksi Non Betalaktam Lafiau Sesuai Dengan Standar Cpob Tahun 2018. Jurnal Ilmiah JKA (Jurnal Kesehatan Aeromedika), 9(2), 9–21. https://doi.org/10.58550/jka.v9i2.231
Yanti, T. T., & Hermawan, R. (2020). Perancangan Sistem Tata Udara Ruang Bersih Kelas B Untuk Ruang Produksi Obat Di Pt.X. Jurnal Mekanikal Teknik Mesin FTUP, 15(1), 13–20.
Zahra, S. R. (2024). Article Review: Cara Pembuatan Obat yang Baik (CPOB) menggunakan Metode Correctove Action and Preventive Action (CAPA) pada Produksi Farmasi Sediaan Padat. 1(1), 9–16.
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Calory Journal : Medical Laboratory Journal
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.