Pharma Stability: Insights, Guidelines, and Expertise
How to Prepare Stability Data for US FDA Submissions Preparing Stability Data for Submissions to the US FDA Introduction Stability data is an essential component of the regulatory submission process for drug products in the United States. The US Food and Drug Administration (FDA) requires comprehensive stability data to ensure that drug products meet their…
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How to Design Stability Studies in Compliance with ICH Q1A(R2) Guidelines Designing Stability Studies in Line with ICH Q1A(R2) Regulations Introduction Stability studies are crucial in ensuring the safety, efficacy, and quality of pharmaceutical products throughout their shelf life. Designing these studies in compliance with the ICH Q1A(R2) guidelines is vital for regulatory approval and…
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SOP for Performing Stability Studies for Lyophilized Products Procedure for Conducting Stability Studies on Lyophilized Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on lyophilized drug products to evaluate their shelf life and storage conditions under various environmental factors such as temperature and humidity….
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How to Conduct Stability Studies for Temperature-Cycling Products under Regulatory Guidelines Stability Testing for Temperature-Cycling Products: A Regulatory Compliance Guide Introduction Temperature-cycling products, such as those subjected to fluctuating temperatures during storage or transportation, require specialized stability testing to ensure their safety, efficacy, and quality. Regulatory authorities, including the US FDA, EMA, and WHO, provide…
How to Implement Stability Testing for High-Volume Manufacturing of Drug Products under Regulatory Guidelines Stability Testing in High-Volume Manufacturing: Ensuring Compliance with Regulatory Guidelines Introduction High-volume manufacturing of drug products requires robust stability testing to ensure product quality, safety, and efficacy throughout the production scale-up and lifecycle. Regulatory authorities, including the US FDA, EMA, and…
How to Address Stability Testing for Drugs under Expedited Approval Pathways Stability Testing for Drugs Under Expedited Approval: Navigating Regulatory Requirements Introduction Drugs developed under expedited approval pathways, such as the FDA’s Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review, require specialized stability testing to ensure their safety, efficacy, and quality while meeting accelerated…
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SOP for Determining Degradation Pathways in Stability Studies Procedure for Identifying Degradation Pathways in Stability Studies 1) Purpose The purpose of this SOP is to provide a standardized procedure for identifying degradation pathways of drug products through stability studies. Understanding these pathways helps in determining the causes of degradation and developing strategies to enhance product…
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How to Conduct Stability Studies for Complex Parenteral Products in Compliance with Regulatory Guidelines Stability Testing for Complex Parenteral Products: A Regulatory Guide Introduction Complex parenteral products, such as injectable emulsions, suspensions, and liposomes, require rigorous stability testing to ensure their safety, efficacy, and quality throughout their shelf life. These products present unique challenges due…
How to Implement Stability Testing for Solid Dispersions in Compliance with Regulatory Guidelines Stability Testing for Solid Dispersions: A Regulatory Compliance Guide Introduction Solid dispersions, which improve the solubility and bioavailability of poorly water-soluble drugs, require specific stability testing to ensure their safety, efficacy, and quality. These formulations present unique challenges due to the potential…
How to Conduct Stability Studies for Combination Vaccines under WHO and FDA Guidelines Stability Testing for Combination Vaccines: A Guide to WHO and FDA Compliance Introduction Combination vaccines, which protect against multiple diseases with a single injection, require rigorous stability testing to ensure their safety, efficacy, and quality. Regulatory authorities, including the WHO and FDA,…
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