Tag: Stability Testing in Novel Packaging

How to Design Stability Studies in Compliance with ICH Q1A(R2) Guidelines

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…

'How to' - Stability Studies

SOP for Performing Stability Studies for Lyophilized Products

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….

Stability Studies SOP

How to Conduct Stability Studies for Temperature-Cycling Products under Regulatory Guidelines

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' - Stability Studies

How to Implement Stability Testing for High-Volume Manufacturing of Drug Products under Regulatory Guidelines

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' - Stability Studies

How to Address Stability Testing for Drugs under Expedited Approval Pathways

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…

'How to' - Stability Studies

SOP for Determining Degradation Pathways in Stability Studies

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…

Stability Studies SOP

How to Conduct Stability Studies for Complex Parenteral Products in Compliance with Regulatory Guidelines

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' - Stability Studies

How to Implement Stability Testing for Solid Dispersions in Compliance with Regulatory Guidelines

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' - Stability Studies

How to Conduct Stability Studies for Combination Vaccines under WHO and FDA Guidelines

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,…

'How to' - Stability Studies

SOP for Conducting Stability Studies for Biologics

SOP for Conducting Stability Studies for Biologics Procedure for Performing Stability Studies for Biologic Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on biologic drug products to evaluate their shelf life and storage conditions under various environmental factors such as temperature, humidity, and light….

Stability Studies SOP