A comprehensive checklist for auditing pharmaceutical stability testing programs to ensure compliance with ICH guidelines, enhance data reliability, and support accurate product shelf life determination.
Pharmaceutical Stability Testing Program Audit Checklist
Get Template
About This Checklist
Stability testing is a critical aspect of pharmaceutical product development and quality assurance, ensuring that drugs maintain their quality, safety, and efficacy throughout their shelf life. This Pharmaceutical Stability Testing Program Audit Checklist is designed to comprehensively evaluate the planning, execution, and documentation of stability studies. By assessing factors such as study design, storage conditions, analytical methods, and data management, this checklist helps pharmaceutical companies maintain compliance with ICH guidelines and regulatory requirements. Implementing this audit process can significantly enhance the reliability of stability data, support accurate expiration dating, and ensure product quality throughout the distribution chain.
Learn moreIndustry
Standard
Workspaces
Occupations
Ensures compliance with ICH stability testing guidelines and regulatory requirements
Improves accuracy in determining product shelf life and expiration dates
Enhances the reliability and integrity of stability data
Supports quality risk management in pharmaceutical development and manufacturing
Facilitates early detection of potential stability issues in drug formulations
