Keep Batch Records Secure—Never Leave Them in Uncontrolled Offices
Remember: GMP documentation such as BMRs must be stored in secure, access-controlled locations—not left unattended in uncontrolled environments.
Why This Matters in GMP
Batch Manufacturing Records (BMRs) are critical GMP documents containing traceable evidence of every stage in drug production. Leaving them in open-access office areas exposes them to unauthorized s, damage, misplacement, or tampering. Uncontrolled handling compromises data integrity, traceability, and audit readiness. GMP requires tight control over documents, especially those impacting batch release. Proper storage safeguards against loss, falsification, or unintentional changes. Once production is complete, BMRs must be transferred to secure QA archives where only trained and authorized personnel can access them.
Regulatory and Compliance Implications
FDA 21 CFR Part 211.180 and 211.186 mandate secure storage and controlled access to GMP documentation. EU GMP Chapter 4 emphasizes the protection of data from unauthorized access or alteration. WHO GMP and Schedule M require documented systems for record control and archival. During audits, inspectors look for evidence of document protection, including locked storage, SOP compliance, and access restrictions. Leaving BMRs in uncontrolled areas may lead to data integrity observations and questions on quality system robustness.
Implementation Best Practices
- Designate secure, access-controlled rooms for BMR review and archival.
- Transfer BMRs to QA-controlled areas immediately after line clearance or batch completion.
- Implement logs for tracking movement and access to GMP records.
- Use locked filing cabinets or digital systems with access rights for document control.
- Train all staff to report misplaced or unattended documents as quality incidents.
Regulatory References
- FDA 21 CFR Part 211.180 – General Requirements
- FDA 21 CFR Part 211.186 – Master Production and Control Records
- EU GMP Chapter 4 – Documentation
- WHO GMP – Documentation Storage and Protection
- Schedule M – GMP Record Keeping and Access Control