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All Journal International Journal of Health, Engineering and Technology
Faradila Ratu Cindana Mo'o
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Agriculture, Biological Sciences & Forestry Chemical Engineering, Chemistry & Bioengineering Dentistry Engineering Health Professions Immunology & microbiology Industrial & Manufacturing Engineering Mechanical Engineering Medicine & Pharmacology Nursing Public Health Veterinary

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The Role Of Stability Testing In Determining The Shelf Life And Storage Conditions Of Pharmaceutical Products: A Narrative Review Najmi Qamariah Tomayahu; Nur Amaliah Abdullah; Nabila Pricilia Pakaya; Sri Meylan H.A Baruadi; Nur Ain Thomas; Faradila Ratu Cindana Mo'o
International Journal of Health Engineering and Technology Vol. 5 No. 2 (2026): Vol 5. No. 2 JULY 2026
Publisher : CV. AFDIFAL MAJU BERKAH

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.55227/ijhet.v5i2.867

Abstract

Stability testing plays an important role in determining the shelf life and appropriate storage conditions of pharmaceutical products. This narrative review aimed to evaluate the role of Stability testing in maintaining the quality, safety, and effectiveness of pharmaceutical products during storage and distribution. Literature was collected from scientific databases including Google Scholar, PubMed, ScienceDirect, and ResearchGate using keywords related to Stability testing and pharmaceutical storage. The reviewed studies showed that Stability testing, including long-term, accelerated, intermediate, and forced degradation studies, can evaluate physical, chemical, and microbiological changes caused by environmental factors such as temperature, humidity, light, and oxidation. Several studies reported that high temperature and humidity accelerated drug degradation, while appropriate storage conditions maintained product stability within pharmacopeial specifications. Stability data are also essential for determining expiration dates, packaging selection, and storage instructions. Therefore, Stability testing is a crucial scientific approach in the pharmaceutical industry to ensure product quality, regulatory compliance, and patient safety throughout the product shelf life.
Development Of Analysis Methods Based On Scientific Approach And Risk-Based Approach In The Pharmaceutical Industry: Narrative Review Fahdalis Alifrizqy Massi; Fajrini Adya Rizki Mokoagow; Siti Najma Bakari; Nur Ain Thomas; Faradila Ratu Cindana Mo'o
International Journal of Health Engineering and Technology Vol. 5 No. 2 (2026): Vol 5. No. 2 JULY 2026
Publisher : CV. AFDIFAL MAJU BERKAH

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.55227/ijhet.v5i2.881

Abstract

The development of analytical methods and quality systems in the pharmaceutical industry is now shifting from the conventional trial and error approach to a systematic, scientific, and risk-based approach to meet international regulatory demands. This article aims to examine the effectiveness of implementing the concepts of Analytical Quality by Design (AQbD), Quality by Design (QbD), and various risk management instruments in improving product quality and operational efficiency in the pharmaceutical industry. Methods: This study is the result of a literature review of 15 scientific journals discussing analytical method development, process validation, product stability, and operational risk management. The analysis shows that the application of AQbD and QbD through parameters such as Analytical Target Profile (ATP) and Design of Experiments (DoE) can increase the robustness of analytical methods and reduce the risk of failures such as Out of Specification (OOS). The use of risk management tools such as Failure Mode and Effect Analysis (FMEA) has proven effective in identifying cross-contamination risks and distribution process failures. The integration of scientific and risk-based approaches has a significant positive impact in ensuring quality consistency, accelerating time-to-market, and supporting compliance with ICH guidelines (Q8, Q9, Q10, Q14).
Co-Authors Fahdalis Alifrizqy Massi Fajrini Adya Rizki Mokoagow Nabila Pricilia Pakaya Najmi Qamariah Tomayahu Nur Ain Thomas Nur Amaliah Abdullah Siti Najma Bakari Sri Meylan H.A Baruadi