Drug Stability in Pharmaceutical Product Development: A Review Based on the International Council for Harmonisation (ICH) Guidelines
DOI:
https://doi.org/10.65310/pyr3kw47Keywords:
Drug Stability, Pharmaceutical Development, Shelf Life, Regulatory Compliance, Quality Assurance.Abstract
Drug stability is a critical parameter in pharmaceutical product development that determines quality, safety, and efficacy throughout the product life cycle. This study aims to analyze the principles and application of stability studies based on the International Council for Harmonization guidelines in the context of formulation development, packaging, and shelf life determination. The method used is a non-empirical literature review of scientific articles published between 2010 and 2024 that are relevant to pharmaceutical stability and quality regulations. The analysis was conducted through a systematic selection process, conceptual data extraction, and comparative synthesis of long-term, accelerated, and intermediate stability test parameters in accordance with ICH standards. The results of the study show that the application of standardized stability study designs, the selection of representative storage conditions, and the periodic evaluation of physicochemical and microbiological changes play an important role in ensuring product quality consistency. The integration of a risk-based approach and validated documentation also improves regulatory compliance and product development efficiency. The harmonization of stability study practices based on ICH guidelines is a strategic foundation for ensuring the acceptance of pharmaceutical products in the global market and protecting patient safety. These findings support scientific decision-making in the registration and distribution process.
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Bhavyasri, K., Vishnumurthy, K. M., Rambabu, D., & Sumakanth, M. (2019). ICH guidelines–“Q” series (quality guidelines)-A review. GSC Biol Pharm Sci, 6(3), 089-106. https://doi.org/10.30574/gscbps.2019.6.3.0034.
Davies, J. G., Gao, D., Kim, Y. J., Harris, R., Cash, P. W., Schofield, T. L., ... & Qin, Q. (2017). ICH Q5C stability testing of biotechnological/biological products. ICH quality guidelines: an implementation guide, 345-373. https://doi.org/10.1002/9781118971147.ch12.
Ghani, S. (2014). ICH Quality Guidelines: Their Global Impact. Therapeutic Delivery Solutions, 367-380. https://doi.org/10.1002/9781118903681.ch13.
Harsanti, B. D., & Chaerunisaa, A. Y. (2021). Review Artikel: Manajemen Risiko Mutu, Metode Serta Penerapannya Dalam Industri Farmasi. Farmaka, 19(1), 77-88. https://doi.org/10.24198/farmaka.v19i1.30720,
Huynh-Ba, K., & Zahn, M. (2009). Understanding ICH guidelines applicable to stability testing. In Handbook of stability testing in pharmaceutical development: regulations, methodologies, and best practices (pp. 21-41). New York, NY: Springer New York. https://doi.org/10.1007/978-0-387-85627-8_3.
Ibrahim, R., Fahlufi, C. F., Cahyana, H. A., Buana, B. S., Aziz, A. M., Saputro, M. R., & Pratama, R. (2026). Review Artikel: Tinjauan Pengujian dan Peningkatan Stabilitas Sediaan Nanoemulsi dari Berbagai Bahan Alam. Majalah Farmasetika, 11(1). https://doi.org/10.24198/mfarmasetika.v11i1.67962.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q1A(R2): Stability Testing of New Drug Substances and Products.
Isnaeni, N. (2025). Studi Stabilitas Baku Pembanding Glukosamin Hidroklorida: Penerapan ISO 17034: 2016 dalam Memastikan Kualitas dan Validitas Pengujian Farmasi. Eruditio: Indonesia Journal of Food and Drug Safety, 5(2), 116-127. https://doi.org/10.54384/eruditio.v5i2.205.
Leghari, Q. A., Anwar, N. T., Syed, Y., Shuja, A. A., & Ali, M. (2025). Ensuring pharmaceutical quality: the role of stability studies and regulatory guidelines: a review. Indus Journal of Bioscience Research, 3(3), 112-122. https://doi.org/10.70749/ijbr.v3i3.942.
Maukar, A. L., & Hakim, A. N. (2018). Relayout Ruang Penyimpanan Sampel Stabilitas Impermeable Berdasarkan Konsep Similarity Dan Popularity Serta Prinsip 5S. Jurnal Ilmiah Teknik Industri, 6(2). https://doi.org/10.24912/jitiuntar.v6i2.4116.
McMahon, M. E., Abbott, A., Babayan, Y., Carhart, J., Chen, C. W., Debie, E., ... & Wu, Y. (2021). Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies: Recommended Revision to ICH Q1/Q5C Stability Guidelines. The AAPS journal, 23(6), 107. https://doi.org/10.1208/s12248-021-00641-6.
Mugni, A. R., & Hasanah, A. N. (2018). Fitosom Sebagai Sistem Penghantar Obat Transdermal: Formulasi Baru Obat Herbal untuk Perkembangan Farmasetika di Indonesia. Farmaka, 16(1), 61-71. https://doi.org/10.24198/jf.v16i1.16854.
Noviani, L. (2023). Edukasi Penyimpanan Dan Penggunaan Obat Yang Benar Pada Masyarakat Rusun Penjaringan, Jakarta Utara. Mitramas: Jurnal Pengabdian dan Pemberdayaan Masyarakat, 1(2), 151-159. https://doi.org/10.25170/mitramas.v1i2.4479.
Ojha, A., & Bhargava, S. (2022). International council for harmonisation (ICH) guidelines. In Regulatory affairs in the pharmaceutical industry (pp. 47-74). Academic Press. https://doi.org/10.1016/B978-0-12-822211-9.00008-3.
Pawar, M. A. K., & Khandelwal, M. H. R. (2019). An overview-international conference on harmonisation and ICH (Q1) stability testing guideline for pharmaceutical development. International Journal for Research in Applied Science and Engineering Technology, 7, 1042-1052. https://doi.org/10.22214/ijraset.2019.12163.
Qomara, W. F., & Musfiroh, I. (2023). Evaluasi Stabilitas dan Inkompatibilitas Sediaan Oral Liquid. Majalah Farmasetika, 8(3), 209-223. https://doi.org/10.24198/mfarmasetika.v8i3.44346.
Rignall, A. (2017). ICHQ1A (R2) stability testing of new drug substance and product and ICHQ1C stability testing of new dosage forms. ICH quality guidelines: an implementation guide, 3-44. https://doi.org/10.1002/9781118971147.ch1.
Salsabila, R., Putri, O. E., Shinta, G. N., Septiani, E. Y., Pernadi, Z. D., Pahlevi, M. R., ... & Sagita, N. D. (2025). Peran Kokristal pada Bahan Aktif Farmasi dalam Meningkatkan Stabilitas Obat. Jurnal Farmasi Ma Chung: Sains, Teknologi, dan Klinis Komunitas, 3(1), 54-66. https://doi.org/10.33479/jfmc.v3i1.58,
Saputro, M. R., Wardhana, Y. W., & Wathoni, N. (2021). Stabilitas Hidrogel dalam Penghantaran Obat. Majalah Farmasetika, 6(5), 421-435. https://doi.org/10.24198/mfarmasetika.v6i5.35705.
Widyastama, R., Dewi, S. T., & Latifah, N. (2025). Review Jurnal: Perbandingan Uji Stabilitas Paracetamol dan Asetosal dalam Sediaan Tablet. Vitalitas Medis: Jurnal Kesehatan dan Kedokteran, 2(3), 117-122. https://doi.org/10.62383/vimed.v2i3.1937.
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Copyright (c) 2026 Indah br Harahap, Ike Maharani, Lirayu Sitompul, Melda Febriayana Hasibuan , Rafiah Nasution, Selvia Nurdea Syahfitri, Cory Linda Futri Hrp (Author)
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