A comprehensive checklist for auditing pharmaceutical stability testing programs, covering study design, sample storage, analytical methods, and data interpretation to ensure compliance with regulatory requirements and maintain product quality.
Pharmaceutical Stability Testing Audit Checklist
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About This Checklist
The Pharmaceutical Stability Testing Audit Checklist is a crucial tool for ensuring the quality, safety, and efficacy of pharmaceutical products throughout their shelf life. This comprehensive checklist addresses key aspects of stability testing programs, including study design, sample storage conditions, analytical methods, and data interpretation. By systematically evaluating stability testing procedures, pharmaceutical companies can maintain compliance with regulatory requirements, optimize product formulations, and make informed decisions about storage conditions and expiration dating. This checklist helps identify potential issues in stability testing processes, ensuring the reliability of stability data and ultimately contributing to patient safety and product quality.
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Ensures compliance with ICH guidelines and pharmacopeia requirements for stability testing
Improves the accuracy and reliability of stability data
Helps in identifying and addressing potential stability issues early in product development
Supports informed decision-making on product shelf life and storage conditions
Facilitates regulatory submissions and approvals
