Check Reagent Expiry Dates Before Use in QC Testing
Remember: Never use reagents in QC labs without verifying their expiry dates — expired reagents compromise test accuracy and compliance.
Why This Matters in GMP
Reagents play a critical role in analytical testing and product release decisions. Using expired or deteriorated reagents can produce inaccurate test results, leading to batch rejection, false failures, or release of non-compliant products. Expiry dates are assigned to ensure chemical stability and reliability of analytical reactions. When lab personnel overlook expiry dates, it reflects a breakdown in data integrity and quality assurance systems. Tests performed with expired reagents may be considered invalid and must be repeated, causing delays and resource wastage. Regular verification of reagent validity ensures that laboratory data is dependable, defensible, and compliant with GMP expectations.
Regulatory and Compliance Implications
FDA 21 CFR Part 211.160 and 211.194 require that laboratory solutions and reagents used in testing be properly identified, labeled, and valid. EU GMP Chapter 6 and WHO GMP mandate the use of qualified, non-expired materials for analytical procedures. Schedule M requires accurate labeling and use of reagents within their validated shelf life. Audit observations frequently include findings related to expired reagents, which are treated as data integrity breaches. Regulatory bodies expect documented procedures for tracking reagent receipt, usage, and disposal after expiry. Failure to follow these protocols can result in invalidated test results, warning letters, and delays in batch release.
Implementation Best Practices
- Label all reagents clearly with date of receipt, opening, and expiry.
- Use color-coded tags or stickers to flag nearing-expiry reagents.
- Maintain a reagent inventory register with auto alerts for expiry.
- Train lab personnel to check expiry dates before every analysis.
- Dispose of expired reagents as per SOP and document the disposal.
Regulatory References
- FDA 21 CFR Part 211.160 – Laboratory Controls
- FDA 21 CFR Part 211.194 – Laboratory Records
- EU GMP Chapter 6 – Quality Control
- WHO GMP – Quality Control of Laboratory Materials
- Schedule M – Laboratory Practices