Pharma Stability: Insights, Guidelines, and Expertise
SOP for Monitoring Microbial Stability in Drug Products Procedure for Assessing Microbial Stability in Pharmaceutical Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for monitoring the microbial stability of drug products over time to ensure they remain free from harmful microorganisms throughout their shelf life. 2) Scope This SOP…
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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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SOP for Conducting Stability Studies for Liquid Dosage Forms Procedure for Performing Stability Studies on Liquid Dosage Forms 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on liquid dosage forms to evaluate their shelf life and storage conditions under various environmental factors such as temperature, humidity,…
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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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SOP for Assessing the Impact of Packaging on Drug Stability Procedure for Evaluating the Effect of Packaging on Drug Stability 1) Purpose The purpose of this SOP is to provide a standardized procedure for assessing the impact of packaging on the stability of drug products. This evaluation helps in selecting the most suitable packaging materials…
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How to Implement Stability Testing for Export Products According to ICH Q1F Guidelines for Conducting Stability Testing for Export Products per ICH Q1F Introduction Stability testing for pharmaceutical products intended for export is crucial to ensure that these products remain safe, effective, and of high quality under various climatic conditions. The ICH Q1F guidelines were…
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How to Interpret ICH Q1B Photostability Testing Guidelines Understanding and Applying ICH Q1B Photostability Testing Standards Introduction Photostability testing is a critical aspect of the stability studies for pharmaceuticals, ensuring that drug substances and products remain stable when exposed to light. The ICH Q1B guidelines provide comprehensive instructions on how to conduct photostability testing to…
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