Do Not Use Outdated MSDS Documents in GMP Workspaces
Remember: GMP demands that only the latest Material Safety Data Sheets (MSDS) be used to ensure accurate chemical handling and workplace safety.
Why This Matters in GMP
Material Safety Data Sheets (MSDS), now referred to as Safety Data Sheets (SDS), are essential for understanding the hazards, handling requirements, and emergency measures related to chemicals used in pharmaceutical manufacturing. An outdated MSDS may omit updated toxicological data, reclassification of hazards, revised PPE requirements, or emergency procedures. Relying on old documents compromises not only personnel safety but also regulatory adherence. GMP requires that all chemical-related documentation be current, readily accessible, and aligned with real-time material usage to safeguard both people and products.
Regulatory and Compliance Implications
FDA 21 CFR Part 211.63 mandates safe and appropriate use of equipment and materials. EU GMP Chapter 3 requires controlled and documented handling of hazardous substances. WHO GMP and Schedule M emphasize the maintenance of up-to-date safety documentation for chemicals stored and used in production. Regulatory inspectors often review chemical storage areas, MSDS binders, and employee awareness during audits. Outdated MSDS usage may result in safety observations, compliance warnings, and even enforcement actions
Implementation Best Practices
- Review all MSDS documents at regular intervals—preferably every 12 months—and update as per supplier revisions.
- Maintain a centralized digital or hard MSDS library that is easily accessible in all GMP zones.
- Assign a responsible person in QA or EHS to monitor updates from raw material suppliers and regulatory agencies.
- Train employees to verify the MSDS revision date before referring to it for any task involving chemical handling.
- Label chemicals with date of receipt and cross-reference against the current MSDS to ensure validity.
Regulatory References
- FDA 21 CFR Part 211.63 – Equipment and Material Safety
- EU GMP Chapter 3 – Premises and Hazardous Material Controls
- WHO GMP – Chemical Safety and Documentation
- Schedule M – Safety Data Management and Review