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All Journal IDJP (Indonesian Journal of Pharmaceutics) Majalah Farmasetika
Shabrina, Ayunda Myela
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Medicine & Pharmacology

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Kajian Risiko Penerapan Good Laboratory Practice terhadap Penetapan Kadar dan Related Substances Shabrina, Ayunda Myela; Rusdiana, Taofik; Verelia, Tisy Ofni
Majalah Farmasetika Vol 11, No 3 (2026)
Publisher : Universitas Padjadjaran

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24198/mfarmasetika.v11i3.70201

Abstract

Dalam melakukan pengembangan dan produksi obat, industri farmasi perlu menerapkan Good Practice (GxP), seperti Good Laboratory Practice (GLP) dan Good Manufacturing Practice (GMP), agar mutu, keamanan, dan efikasi produk terjamin. Salah satu aspek yang tercantum dalam GMP adalah Quality Risk Management (QRM) atau manajemen risiko mutu. Manajemen risiko mutu diterapkan pada berbagai tahapan produksi obat, termasuk analisis kadar dan related substances. Penelitian ini disusun untuk menganalisis dan menilai potensi risiko penerapan GLP pada tahap penetapan kadar dan related substances zat aktif serta produk jadi di industri farmasi “XYZ” menggunakan metode Failure Mode and Effects Analysis (FMEA). Penelitian dilakukan secara observasional berdasarkan dokumentasi industri farmasi “XYZ”. Hasil penelitian berupa hasil kajian risiko yang dianalisis dan dinilai berdasarkan Risk Priority Number (RPN) serta dikategorikan sebagai risiko tinggi, menengah, dan rendah. Beberapa pengendalian yang dapat dilakukan untuk mengurangi risiko pada tahap penetapan kadar dan related substances adalah memastikan personel terkualifikasi, alat terkalibrasi, metode tervalidasi, kegiatan terdokumentasi, serta perhitungan terstandardisasi. Pada industri “XYZ”, pengendalian risiko telah berhasil dilakukan. Melalui pengendalian tersebut, potensi kegagalan dalam tahap penetapan kadar dan related substances di industri farmasi dapat diminimalkan.
Mechanism of Emulsion Formulation and Substances in Maintaining Skin Hydration Shabrina, Ayunda Myela; Simanjuntak, Aprilia Artha Pratama; Sylvia Nurrasjid2, Evi; Amalia, Eri
Indonesian Journal of Pharmaceutics Vol 7, Issue 2, May - August 2025
Publisher : Universitas Padjadjaran (Unpad)

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24198/idjp.v7i2.69834

Abstract

Proper skin hydration is essential for maintaining healthy skin and protecting it from environmental damage. A thorough understanding of the skin’s structure can help researchers identify its layers and components, leading to the development of effective skin hydration formulations. Emulsions are commonly used because they combine water and oil phases, along with ingredients that preserve hydration and enhance chemical penetration through the stratum corneum. Consequently, emulsions are prevalent in skincare and cosmetic products, which are often supplemented with humectants, occlusive agents, and emollients to enhance their efficacy. This study explores the mechanisms through which emulsions support skin hydration, focusing on the roles of water and oil in moisturizing and serving as a skin barrier, as well as the functions of humectants, occlusive agents, and emollients. In conclusion, the stratum corneum is critical for maintaining skin hydration by regulating the water and oil content within its cells and the lipid-rich intercellular spaces. Humectants, occlusive agents, and emollients each enhance hydration through unique mechanisms. We hope this article will assist researchers in developing highly effective, hydrating skincare and cosmetic products.
Co-Authors Amalia, Eri Simanjuntak, Aprilia Artha Pratama Sylvia Nurrasjid2, Evi Taofik Rusdiana Verelia, Tisy Ofni