Do Not Access QA-Reviewed Records Without Proper Authorization

Unauthorized Access to QA-Reviewed Records Is Prohibited in GMP

Remember: Once GMP documents are QA-reviewed and archived, they must be accessed only by authorized personnel to protect data integrity.

Why This Matters in GMP

QA-reviewed records—such as batch manufacturing records (BMRs), deviation reports, or analytical logs—are official GMP documents used to verify product release, audit trails, and compliance evidence. Allowing unauthorized personnel to access or modify these documents undermines data integrity, audit readiness, and traceability. GMP guidelines require that once reviewed and approved, documents be secured from tampering or accidental modification. This principle applies equally to paper and electronic systems. Any unauthorized changes, deletions, or data exports without QA approval violate core GMP standards and compromise product legality and safety.

Also Read: Label In-Process Samples with Date and Initials for Traceability

Regulatory and Compliance Implications

FDA 21 CFR Part 211.180 and 211.186 require controlled access to official records and retention of their integrity. EU GMP Chapter 4 and WHO GMP stress strict document control, including version management and access logs. Schedule M mandates QA oversight on all finalized GMP documentation. Auditors inspect record access logs, electronic system controls, and paper storage areas. Uncontrolled access is treated as a critical observation and may be flagged as a data integrity violation. Only designated QA personnel or approved roles should retrieve, review, or finalized records.

Implementation Best Practices

Restrict access to archived GMP records through secure cabinets or electronic access controls.
Define user roles in document systems—view-only vs. permissions with audit trails.
Maintain access logs and review them periodically to detect any unauthorized activity.
Train personnel on documentation security protocols and consequences of non-compliance.
Include a document request process where QA reviews and approves any file retrievals.

Also Read: Schedule M (Revised) GMP Guidelines for API Manufacturing in India

Regulatory References

FDA 21 CFR Part 211.180 – Record Retention and Access
FDA 21 CFR Part 211.186 – Master Production and Control Records
EU GMP Chapter 4 – Documentation
WHO GMP – Document Control and Record Management
Schedule M – QA Document Security and Access Policies