Tag: Drug 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

SOP for Conducting Stability Studies for Liquid Dosage Forms

SOP for Conducting Stability Studies for Liquid Dosage Forms Procedure for Performing Stability Studies on Liquid Dosage Forms 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on liquid dosage forms to evaluate their shelf life and storage conditions under various environmental factors such as temperature, humidity,…

Stability Studies SOP

How to Conduct Bracketing and Matrixing Studies per ICH Q1D

How to Conduct Bracketing and Matrixing Studies per ICH Q1D Implementing Bracketing and Matrixing Designs According to ICH Q1D Guidelines Introduction Bracketing and matrixing are two scientifically sound approaches that can be employed in stability testing to reduce the number of stability tests required while still ensuring product quality over time. The ICH Q1D guideline…

'How to' - Stability Studies

How to Ensure Compliance with US FDA Stability Testing Requirements

How to Ensure Compliance with US FDA Stability Testing Requirements Achieving Compliance with US FDA Stability Testing Standards Introduction Stability testing is a critical requirement for ensuring that pharmaceutical products maintain their quality, safety, and efficacy throughout their shelf life. The US Food and Drug Administration (FDA) mandates specific stability testing guidelines under the Code…

'How to' - Stability Studies

SOP for Assessing the Impact of Packaging on Drug Stability

SOP for Assessing the Impact of Packaging on Drug Stability Procedure for Evaluating the Effect of Packaging on Drug Stability 1) Purpose The purpose of this SOP is to provide a standardized procedure for assessing the impact of packaging on the stability of drug products. This evaluation helps in selecting the most suitable packaging materials…

Stability Studies SOP

How to Implement Stability Testing for Export Products According to ICH Q1F

How to Implement Stability Testing for Export Products According to ICH Q1F Guidelines for Conducting Stability Testing for Export Products per ICH Q1F Introduction Stability testing for pharmaceutical products intended for export is crucial to ensure that these products remain safe, effective, and of high quality under various climatic conditions. The ICH Q1F guidelines were…

'How to' - Stability Studies

How to Interpret ICH Q1B Photostability Testing Guidelines

How to Interpret ICH Q1B Photostability Testing Guidelines Understanding and Applying ICH Q1B Photostability Testing Standards Introduction Photostability testing is a critical aspect of the stability studies for pharmaceuticals, ensuring that drug substances and products remain stable when exposed to light. The ICH Q1B guidelines provide comprehensive instructions on how to conduct photostability testing to…

'How to' - Stability 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