Stability Studies SOP

The purpose of this SOP is to provide a standardized procedure for conducting stability testing for drug products intended for export to markets covered by ICH Q1F guidelines to ensure compliance with international regulatory standards.
Click to read the full article.

The purpose of this SOP is to provide guidance on conducting and interpreting photostability testing in accordance with ICH Q1B guidelines to ensure that drug substances and products are not adversely affected by exposure to light.
Click to read the full article.

The purpose of this SOP is to establish a procedure for conducting stability testing in compliance with the World Health Organization (WHO) guidelines to ensure the safety, efficacy, and quality of pharmaceutical products.
Click to read the full article.

The purpose of this SOP is to provide a standardized procedure for preparing and compiling stability data in a format suitable for submission to the US FDA to support New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
Click to read the full article.

The purpose of this SOP is to establish a standardized approach for designing stability studies in compliance with the ICH Q1A(R2) guidelines to ensure that drug substances and products maintain their safety, quality, and efficacy throughout their shelf life.
Click to read the full article.

The purpose of this SOP is to outline a standard procedure for conducting stability studies on drug products exposed to extreme environmental conditions, such as high temperatures, freezing, and varying humidity levels. These stability studies are crucial to confirm that the drug products maintain their safety, efficacy, and quality throughout their shelf life when subjected to these challenging conditions.
Click to read the full article.

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on drug products under extreme conditions. Stability testing ensures that drug products maintain their safety, efficacy, and quality when exposed to extreme temperatures, humidity, and light conditions.
Click to read the full article.

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on temperature-sensitive biologics. Stability testing is necessary to ensure that these biologics maintain their safety, efficacy, and quality under various storage conditions throughout their shelf life.
Click to read the full article.

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on sterile products. Stability testing is essential to ensure that sterile products maintain their sterility, safety, efficacy, and quality under various storage conditions throughout their shelf life.
Click to read the full article.

The purpose of this SOP is to provide a standardized procedure for conducting stability studies on enzyme-based drugs. Stability testing is essential to ensure that enzyme-based drugs maintain their activity, safety, efficacy, and quality throughout their shelf life under various storage conditions.
Click to read the full article.