Tag: Stability System

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…

Read More “How to Conduct Stability Testing in Accordance with WHO Guidelines” »

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…

Read More “How to Prepare Stability Data for US FDA Submissions” »

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…

Read More “How to Design Stability Studies in Compliance with ICH Q1A(R2) 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…

Read More “How to Conduct Stability Studies for Temperature-Cycling 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…

Read More “How to Implement Stability Testing for High-Volume Manufacturing of Drug Products under Regulatory Guidelines” »

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…

Read More “How to Address Stability Testing for Drugs under Expedited Approval Pathways” »

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…

Read More “How to Conduct Stability Studies for Complex Parenteral Products 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…

Read More “How to Implement Stability Testing for Solid Dispersions in Compliance with Regulatory Guidelines” »