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All Journal Jurnal Mahasiswa Ilmu Kesehatan Obat: Jurnal Riset Ilmu Farmasi dan Kesehatan
Ella Fazila
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Health Professions Nursing Public Health

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Analisis Risiko Kualifikasi Pemasok dan Pendekatan Mitigasi Risikonya dalam Manajemen Rantai Pasok Industri Farmasi Ella Fazila; Sandra Megantara; Gracia Anastasya
Jurnal Mahasiswa Ilmu Kesehatan Vol. 3 No. 2 (2025): Jurnal Mahasiswa Ilmu Kesehatan
Publisher : STIKes Ibnu Sina Ajibarang

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.59841/jumkes.v3i2.2536

Abstract

Pharmaceutical products play a crucial role in supporting medical interventions to prevent, treat, and cure diseases, making their availability and quality key factors in healthcare services. Therefore, the pharmaceutical supply chain must ensure the availability of medicines in adequate quantities and meet quality standards. Supplier qualification is a critical step in supply chain management aimed at ensuring quality, sustainability, and compliance with regulations. This article analyzes the main risks in the supplier qualification process, such as quality risks, compliance risks, and supply disruptions. Risk mitigation strategies, such as regular audits, source diversification, and the implementation of digital technologies, play an important role in enhancing the efficiency, flexibility, and sustainability of the pharmaceutical supply chain, thereby supporting the competitiveness of the industry in consistently meeting market demands and complying with stringent regulatory standards. Through this research, it is hoped that strategic guidelines can be produced to improve the efficiency of pharmaceutical supply chain risk management, resulting in a positive impact on the overall healthcare system.
Perumusan Corrective Action and Preventive Action (CAPA) pada Salah Satu Pedagang Besar Farmasi di Kota Bandung Ella Fazila; Norisca Aliza Putriana
OBAT: Jurnal Riset Ilmu Farmasi dan Kesehatan Vol. 3 No. 1 (2025): January: OBAT: Jurnal Riset Ilmu Farmasi dan Kesehatan
Publisher : Asosiasi Riset Ilmu Kesehatan Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.61132/obat.v3i1.1030

Abstract

Pharmaceutical Wholesalers or commonly known as PBFs are companies in the form of legal entities that have permits to procure, store and distribute large quantities of pharmaceutical supplies in accordance with the provisions of applicable laws and regulations. PBF must implement a quality system that includes quality risk management principles. An effective quality management system must include a Corrective Action and Preventive Action (CAPA) process to address deviations and prevent the same problems from occurring again in the future. The research was carried out by reviewing cases found by the Center for Food and Drug Monitoring (BBPOM) at PBF "X" and then continuing with an analysis of corrective actions and corrective actions that needed to be taken to overcome these cases of deviation. The results of the research show that the preparation of the CAPA by PBF PBF “X” has implemented most of the provisions contained in the CDOB guidelines well.
Gap Analysis CPOB 2018 Terhadap Rancangan Revisi CPOB 2024 Aneks 1 Pembuatan Produk Steril Aspek Peralatan, Sarana Penunjang, dan Personalia Gracia Anastasya; Taofik Rusdiana; Ella Fazila
OBAT: Jurnal Riset Ilmu Farmasi dan Kesehatan Vol. 3 No. 2 (2025): March: OBAT: Jurnal Riset Ilmu Farmasi dan Kesehatan
Publisher : Asosiasi Riset Ilmu Kesehatan Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.61132/obat.v3i2.1136

Abstract

The pharmaceutical industry operates under a strict regulatory framework to ensure that the products produced are safe, of high quality, and effective. These regulations are continuously updated to keep up with advancements in science, technological developments, and global demands for higher quality standards. The pharmaceutical industry also faces the challenge of global regulatory harmonization, such as standards set by WHO and PIC/S. These regulations are designed to ensure drug quality from development to distribution. Changes in Good Manufacturing Practices (GMP) regulations are crucial for improving pharmaceutical production quality in Indonesia. This study aims to conduct a gap analysis between the 2018 GMP and the draft 2024 GMP Annex 1, particularly in terms of equipment, supporting facilities, and personnel. The method used is a comparative analysis by comparing the provisions of the 2018 GMP with the draft 2024 GMP. The gap analysis results between the 2018 GMP and the draft 2024 GMP Annex 1 in terms of equipment, supporting facilities, personnel, and sterile product completion indicate significant changes in the adopted standards. The proposed 2024 GMP revision introduces substantial improvements in sterile product manufacturing standards. As part of efforts to enhance global competitiveness, the Indonesian pharmaceutical industry must continue to adapt to dynamic technological and regulatory changes. By implementing various strategies—including substantial investments in modern equipment, adjustments to supporting facilities, and capacity building for personnel—the Indonesian pharmaceutical industry can meet global standards while ensuring the availability of safe, high-quality, and effective sterile products for the public.
Co-Authors Gracia Anastasya NORISCA ALIZA PUTRIANA SANDRA MEGANTARA Taofik Rusdiana