Tag: Stability testing

Optimize Stability Timelines by Starting Real-Time and Accelerated Studies Together

Understanding the Tip: Why initiate both studies together: Starting real-time and accelerated stability studies simultaneously ensures comprehensive data collection from day one. Real-time data builds the case for long-term shelf life, while accelerated data offers early insights into product behavior under stress. This dual-track approach avoids delays in development and supports faster decision-making for regulatory…

Stability Study Tips

SOP for Documenting Stability Studies for New Drug Applications (NDAs) to the US FDA

SOP for Documenting Stability Studies for New Drug Applications (NDAs) to the US FDA Standard Operating Procedure for Stability Study Documentation for NDAs 1) Purpose The purpose of this SOP is to provide a standardized procedure for documenting stability studies in support of New Drug Applications (NDAs) to the US FDA to ensure compliance with…

Stability Studies SOP

Run Real-Time and Accelerated Stability Studies in Parallel

Stability Study Tips

SOP for Conducting Stability Studies for Modified Release Products per FDA and ICH Guidelines

SOP for Conducting Stability Studies for Modified Release Products per FDA and ICH Guidelines Standard Operating Procedure for Stability Testing of Modified Release Products 1) Purpose The purpose of this SOP is to provide a standardized approach for conducting stability studies for modified-release products in compliance with US FDA and ICH guidelines to ensure their…

Stability Studies SOP

SOP for Designing Stability Studies for Combination Products as per Regulatory Guidelines

SOP for Designing Stability Studies for Combination Products as per Regulatory Guidelines Standard Operating Procedure for Stability Testing of Combination Products 1) Purpose The purpose of this SOP is to establish a procedure for designing stability studies for combination products, such as drug-device combinations, in compliance with applicable regulatory guidelines to ensure their safety, efficacy,…

Stability Studies SOP

SOP for Implementing ICH Q1E for Stability Data Evaluation

SOP for Implementing ICH Q1E for Stability Data Evaluation Standard Operating Procedure for Stability Data Evaluation Following ICH Q1E 1) Purpose The purpose of this SOP is to provide a standardized procedure for evaluating stability data in compliance with ICH Q1E guidelines to ensure the quality, safety, and efficacy of drug substances and products throughout…

Stability Studies SOP

SOP for Conducting Stability Studies for Drug Substances Under US FDA Guidelines

SOP for Conducting Stability Studies for Drug Substances Under US FDA Guidelines Standard Operating Procedure for Stability Testing of Drug Substances According to FDA Guidelines 1) Purpose The purpose of this SOP is to outline the procedure for conducting stability studies for drug substances in compliance with US FDA guidelines to ensure their quality, safety,…

Stability Studies SOP

SOP for Developing a Stability-Indicating Method in Compliance with ICH Q2(R1)

SOP for Developing a Stability-Indicating Method in Compliance with ICH Q2(R1) Standard Operating Procedure for Creating a Stability-Indicating Method Following ICH Q2(R1) 1) Purpose The purpose of this SOP is to provide a standardized procedure for developing a stability-indicating analytical method that complies with ICH Q2(R1) guidelines to ensure the accuracy, precision, and reliability of…

Stability Studies SOP

SOP for Addressing Stability Issues in ANDA Submissions to the US FDA

SOP for Addressing Stability Issues in ANDA Submissions to the US FDA Standard Operating Procedure for Handling Stability Issues in ANDA Submissions 1) Purpose The purpose of this SOP is to establish a procedure for addressing stability issues in Abbreviated New Drug Applications (ANDA) submissions to the US FDA to ensure compliance with regulatory requirements….

Stability Studies SOP

SOP for Conducting Stability Studies for Biologics Following FDA Guidelines

SOP for Conducting Stability Studies for Biologics Following FDA Guidelines Standard Operating Procedure for Stability Testing of Biologics According to FDA Guidelines 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on biologic drug products in compliance with US FDA guidelines, ensuring the product’s safety, potency, and…

Stability Studies SOP