Tag: Photostability testing

How to Prepare a Stability Protocol in Accordance with ICH Q1A(R2) Developing a Stability Protocol Following ICH Q1A(R2) Guidelines Introduction A well-defined stability protocol is critical for conducting stability studies that are compliant with regulatory requirements. The ICH Q1A(R2) guidelines provide a comprehensive framework for the stability testing of drug substances and products, including the…

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How to Conduct Stability Testing for Drug Products Under ASEAN Guidelines Guidelines for Stability Testing of Drug Products in ASEAN Countries Introduction Stability testing is essential to ensure that drug products maintain their quality, safety, and efficacy throughout their shelf life. The Association of Southeast Asian Nations (ASEAN) has established specific guidelines for stability testing…

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How to Perform Stability Studies Following EMA (European Medicines Agency) Guidelines Conducting Stability Studies in Compliance with EMA Requirements Introduction Stability studies are a fundamental aspect of the pharmaceutical development process, ensuring that a product maintains its intended quality, safety, and efficacy throughout its shelf life. The European Medicines Agency (EMA) has established specific guidelines…

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How to Report Stability Data in Common Technical Document (CTD) Format Reporting Stability Data in CTD Format: A Comprehensive Guide Introduction Stability data is a crucial component of regulatory submissions for pharmaceutical products, providing evidence of the product’s quality, safety, and efficacy over its shelf life. The Common Technical Document (CTD) format, developed by the…

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How to Conduct Bracketing and Matrixing Studies per ICH Q1D Implementing Bracketing and Matrixing Designs According to ICH Q1D Guidelines Introduction Bracketing and matrixing are two scientifically sound approaches that can be employed in stability testing to reduce the number of stability tests required while still ensuring product quality over time. The ICH Q1D guideline…

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How to Ensure Compliance with US FDA Stability Testing Requirements Achieving Compliance with US FDA Stability Testing Standards Introduction Stability testing is a critical requirement for ensuring that pharmaceutical products maintain their quality, safety, and efficacy throughout their shelf life. The US Food and Drug Administration (FDA) mandates specific stability testing guidelines under the Code…

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