Pharma Stability: Insights, Guidelines, and Expertise
Stability Study Protocol Comprehensive Stability Study Protocol for Drug Products This protocol outlines the procedures for conducting stability studies to evaluate the shelf life of drug products under specified conditions. The study assesses physical, chemical, biological, and microbiological properties of the drug over time. Parameter Details Product Name [Drug Product Name] Batch Number [Batch Number]…
SOP for Establishing a Stability-Indicating Method Procedure for Developing a Stability-Indicating Method for Pharmaceuticals 1) Purpose The purpose of this SOP is to provide a standardized procedure for developing a stability-indicating method to detect the degradation products and measure the potency of pharmaceuticals over time. 2) Scope This SOP applies to all drug substances and…
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How to Conduct Stability Testing in Accordance with WHO Guidelines Conducting Stability Testing as per WHO Requirements Introduction Stability testing is an integral part of pharmaceutical product development, ensuring that the product maintains its safety, efficacy, and quality throughout its shelf life. The World Health Organization (WHO) provides comprehensive guidelines for conducting stability testing, which…
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Analytical Data Record for Conducting Stability Studies for Recombinant Proteins Comprehensive Analytical Data Record for Stability Studies of Recombinant Proteins This template captures stability data for recombinant proteins, focusing on protein stability, activity retention, degradation products, and sterility over time under various conditions. Parameter Details Product Name [Recombinant Protein Name] Batch Number [Batch Number] Test…
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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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Analytical Data Record for Evaluating Stability for Drugs in Aseptic Processing Comprehensive Analytical Data Record for Stability Studies of Drugs in Aseptic Processing This template records data from stability studies conducted on drugs manufactured using aseptic processing techniques. The focus is on sterility, degradation, and physical integrity. Parameter Details Product Name [Aseptic Processed Drug Name]…
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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…
Analytical Data Record for Performing Stability Studies for Drugs with Special Storage Requirements Comprehensive Analytical Data Record for Stability Studies of Drugs with Special Storage Requirements This template is used to record stability data for drugs that have specific storage requirements, such as temperature-sensitive or humidity-sensitive products. Parameter Details Product Name [Product Name] Batch Number…