Generic Drug Stability Testing: ICH Guidelines Ensure Consistent Framework Across Regions

Pharmaceutical manufacturers conduct stability testing of generic drugs to ensure patient safety and meet regulatory requirements. Key elements of this testing include adherence to international guidelines, developing robust testing protocols, managing and analyzing data, and maintaining regulatory compliance. Generic drug manufacturers follow the International Conference on Harmonisation (ICH) guidelines, which provide a framework for consistent stability testing across different regions. Furthermore, manufacturers develop specific stability testing protocols that identify the critical quality attributes (CQAs) of the drug product. These protocols also determine the appropriate testing methods and the frequency of testing. They also manage and analyze the resulting data, using statistical methods to interpret the results and make informed decisions about the drug product’s stability. Staying up-to-date with Good Manufacturing Practice (GMP) regulations and specific regional requirements is another necessary component for regulatory compliance.

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Date: April 14, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後