Regulatory Guidelines

Stability testing is a critical component in the development of biologics, ensuring these complex and sensitive products maintain their safety, efficacy, and quality throughout their lifecycle. The U.S. Food and Drug Administration (FDA) provides specific guidance for stability testing of new and emerging biologics, such as gene therapies, cell-based treatments, and mRNA vaccines. This article explores FDA requirements, challenges, and best practices for conducting stability testing for biologics in compliance with regulatory standards.
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Stability testing is a critical component of pharmaceutical development, ensuring drug products retain their quality, safety, and efficacy throughout their shelf life. However, the pharmaceutical industry faces challenges due to differing stability testing requirements across regulatory agencies worldwide. Harmonization of stability testing guidelines aims to streamline these processes, reducing redundancies and enabling faster market access. This article explores the progress, challenges, and trends in harmonizing stability testing requirements for global drug approvals.
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Photostability testing evaluates the impact of light exposure on pharmaceutical products to ensure they remain safe, effective, and visually acceptable throughout their lifecycle. The International Council for Harmonisation (ICH) guideline Q1B provides a comprehensive framework for conducting photostability testing. This step-by-step guide explores the requirements for regulatory compliance under ICH Q1B, detailing practical strategies to ensure effective implementation.
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Stability testing is a critical component of pharmaceutical development, ensuring that generic drugs meet the required quality, safety, and efficacy standards over their shelf life. The ASEAN Stability Guidelines provide a harmonized framework for evaluating the stability of pharmaceuticals in Southeast Asia, focusing on the region’s tropical climate (Climatic Zone IVb). However, implementing these guidelines for generic pharmaceuticals presents unique challenges. This article explores common hurdles and practical solutions for ASEAN stability testing, helping manufacturers achieve compliance and maintain product quality.
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Biopharmaceuticals, such as monoclonal antibodies, vaccines, and recombinant proteins, are among the most innovative yet sensitive pharmaceutical products. Stability testing for these products is critical for maintaining their quality, safety, and efficacy throughout their lifecycle. The U.S. Food and Drug Administration (FDA) has established comprehensive guidelines for the stability testing of biopharmaceuticals, ensuring they meet stringent regulatory standards. This article provides actionable insights into FDA stability guidelines and offers strategies for achieving compliance and success in this challenging domain.
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