Stability Study Protocol and Execution (ICH Q1A/Q1E)

This document defines the protocol and execution plan for stability studies conducted in accordance with ICH Q1A and ICH Q1E guidelines. It outlines the procedures for evaluating how the quality of a product changes over time under the influence of environmental factors such as temperature, humidity, and light. The protocol includes study design, storage conditions, testing intervals, sample requirements, acceptance criteria, and documentation practices. Its purpose is to generate reliable stability data to establish the product’s shelf life, recommended storage conditions, and retest period, while ensuring continued safety, efficacy, and quality throughout the product lifecycle.