Pharma Stability: Insights, Guidelines, and Expertise
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…
Read More “SOP for Assessing the Impact of Packaging on Drug Stability” »
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…
Read More “How to Implement Stability Testing for Export Products According to ICH Q1F” »
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…
Read More “How to Interpret ICH Q1B Photostability Testing Guidelines” »
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…
Read More “SOP for Establishing a Stability-Indicating Method” »
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…
Read More “How to Conduct Stability Testing in Accordance with WHO Guidelines” »
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…
Read More “How to Prepare Stability Data for US FDA Submissions” »
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…
Read More “How to Design Stability Studies in Compliance with ICH Q1A(R2) Guidelines” »
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….
Read More “SOP for Performing Stability Studies for Lyophilized Products” »
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 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…