Tag: Stability studies

SOP for Evaluating Stability of Combination Products

SOP for Evaluating Stability of Combination Products Procedure for Conducting Stability Studies on Combination Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for evaluating the stability of combination drug products to ensure their quality, safety, and efficacy throughout their shelf life under various environmental conditions. 2) Scope This…

Stability Studies SOP

How to Address Stability Issues in ANDA Submissions to the US FDA

How to Address Stability Issues in ANDA Submissions to the US FDA Handling Stability Challenges in ANDA Submissions to the FDA Introduction Abbreviated New Drug Application (ANDA) submissions to the US FDA require comprehensive stability data to demonstrate that a generic drug product meets the same quality, safety, and efficacy standards as its reference listed…

'How to' - Stability Studies

How to Conduct Stability Studies for Biologics Following FDA Guidelines

How to Conduct Stability Studies for Biologics Following FDA Guidelines Guidelines for Stability Testing of Biologics as per FDA Requirements Introduction Biologics, or biological products, require rigorous stability studies to ensure their safety, efficacy, and quality over their shelf life due to their complex nature and sensitivity to environmental factors. The US FDA provides specific…

'How to' - Stability Studies

How to Implement Stability Studies for Drug Products in Compliance with US FDA CFR Title 21

How to Implement Stability Studies for Drug Products in Compliance with US FDA CFR Title 21 Conducting Stability Studies for Drug Products as per US FDA CFR Title 21 Requirements Introduction Stability studies are essential for ensuring that drug products meet their quality, safety, and efficacy standards throughout their shelf life. The US Food and…

'How to' - Stability Studies

SOP for Performing Stability Studies for Generic Drugs

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

Stability Studies SOP

How to Prepare a Stability Protocol in Accordance with ICH Q1A(R2)

How to Prepare a Stability Protocol in Accordance with ICH Q1A(R2) Developing a Stability Protocol Following ICH Q1A(R2) Guidelines Introduction A well-defined stability protocol is critical for conducting stability studies that are compliant with regulatory requirements. The ICH Q1A(R2) guidelines provide a comprehensive framework for the stability testing of drug substances and products, including the…

'How to' - Stability Studies

SOP for Monitoring Microbial Stability in Drug Products

SOP for Monitoring Microbial Stability in Drug Products Procedure for Assessing Microbial Stability in Pharmaceutical Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for monitoring the microbial stability of drug products over time to ensure they remain free from harmful microorganisms throughout their shelf life. 2) Scope This SOP…

Stability Studies SOP

How to Conduct Stability Testing for Drug Products Under ASEAN Guidelines

How to Conduct Stability Testing for Drug Products Under ASEAN Guidelines Guidelines for Stability Testing of Drug Products in ASEAN Countries Introduction Stability testing is essential to ensure that drug products maintain their quality, safety, and efficacy throughout their shelf life. The Association of Southeast Asian Nations (ASEAN) has established specific guidelines for stability testing…

'How to' - Stability Studies

How to Perform Stability Studies Following EMA (European Medicines Agency) Guidelines

How to Perform Stability Studies Following EMA (European Medicines Agency) Guidelines Conducting Stability Studies in Compliance with EMA Requirements Introduction Stability studies are a fundamental aspect of the pharmaceutical development process, ensuring that a product maintains its intended quality, safety, and efficacy throughout its shelf life. The European Medicines Agency (EMA) has established specific guidelines…

'How to' - Stability Studies

How to Report Stability Data in Common Technical Document (CTD) Format

How to Report Stability Data in Common Technical Document (CTD) Format Reporting Stability Data in CTD Format: A Comprehensive Guide Introduction Stability data is a crucial component of regulatory submissions for pharmaceutical products, providing evidence of the product’s quality, safety, and efficacy over its shelf life. The Common Technical Document (CTD) format, developed by the…

'How to' - Stability Studies