Pharmaceutical Stability Testing Program Audit Checklist

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
by: audit-now
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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.

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Industry

Pharmaceuticals

Standard

ICH Q1A(R2), ICH Q1B, ICH Q1C, FDA 21 CFR Part 211

Workspaces

Pharmaceutical stability testing laboratories

Occupations

Stability Testing Specialist
Quality Assurance Manager
Analytical Chemist
Regulatory Affairs Specialist
Pharmaceutical Scientist

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