All Courses SOP for Stability Studies
SOP for Stability Studies
Stability studies are conducted to evaluate how the quality of a drug substance or drug product varies with time under the influence of environmental factors such as temperature, humidity, and light.
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1 Lessons

This SOP outlines the procedure for the planning, execution, documentation, and evaluation of stability studies in accordance with ICH guidelines (e.g., ICH Q1A(R2)). It includes the selection of batches, labeling and storage conditions, sampling intervals, testing requirements, data analysis, and reporting. It also defines responsibilities of Quality Assurance, Quality Control, and Stability Coordinators in managing the study, ensuring regulatory compliance, and maintaining data integrity.

Course Content
SOP for Stability Studies - Training and Assessment