Tag: Photostability testing

SOP for Preparing a Stability Protocol in Accordance with ICH Q1A(R2)

SOP for Preparing a Stability Protocol in Accordance with ICH Q1A(R2) Guidelines for Developing a Stability Protocol as per ICH Q1A(R2) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for preparing a stability protocol for drug substances and drug products in compliance with the ICH Q1A(R2) guidelines. This…

Stability Studies SOP

Photostability and Oxidative Stability Studies in Pharma: Complete Guide

Photostability and Oxidative Stability Studies, Stability Testing Types

Stability Testing Types: Comprehensive Guide for Pharma Professionals

Stability Testing Types: Comprehensive Guide for Pharma Professionals In-Depth Guide to Pharmaceutical Stability Testing Methods and Classifications Introduction Stability testing is a fundamental process in pharmaceutical development and manufacturing. It determines how the quality of a drug substance or product varies with time under the influence of environmental factors such as temperature, humidity, and light….

Stability Testing Types

SOP for Conducting Stability Studies in Compliance with Japanese Regulatory Requirements (PMDA)

SOP for Conducting Stability Studies in Compliance with Japanese Regulatory Requirements (PMDA) Standard Operating Procedure for Stability Testing According to PMDA Guidelines 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies in compliance with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) guidelines to ensure the safety,…

Stability Studies SOP

SOP for Managing Stability Testing of Post-Approval Changes According to US FDA Guidelines

SOP for Managing Stability Testing of Post-Approval Changes According to US FDA Guidelines Standard Operating Procedure for Stability Testing Following Post-Approval Changes 1) Purpose The purpose of this SOP is to provide a standardized approach for managing stability testing following post-approval changes to drug substances and products in compliance with US FDA guidelines.

Stability Studies SOP

Follow ICH Q1B for Photostability Testing Using Appropriate Light Sources

Understanding the Tip: Why photostability testing is important: Many pharmaceutical products are susceptible to light-induced degradation, which can lead to reduced potency, the formation of harmful impurities, or changes in physical appearance. Photostability testing identifies these risks early. This allows manufacturers to define appropriate packaging and labeling that protect the product and extend shelf life….

Stability Study Tips

SOP for Applying ICH Q1C Guidelines for Stability Testing of New Dosage Forms

SOP for Applying ICH Q1C Guidelines for Stability Testing of New Dosage Forms Standard Operating Procedure for Stability Testing of New Dosage Forms as per ICH Q1C 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability testing of new dosage forms in compliance with ICH Q1C guidelines to…

Stability Studies SOP

SOP for Developing Stability Study Reports for ANDA Submissions

SOP for Developing Stability Study Reports for ANDA Submissions Standard Operating Procedure for Preparing Stability Reports for ANDAs 1) Purpose The purpose of this SOP is to provide a standardized procedure for developing stability study reports for Abbreviated New Drug Applications (ANDAs) to the US FDA, ensuring compliance with regulatory requirements. 2) Scope This SOP…

Stability Studies SOP

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

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