Tag: Pharmaceutical Studies

SOP for Establishing a Stability-Indicating Method

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…

Stability Studies SOP

How to Conduct Stability Testing in Accordance with WHO Guidelines

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…

'How to' - Stability Studies

How to Prepare Stability Data for US FDA Submissions

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…

'How to' - Stability Studies

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