Avoid Manual Data Corrections Without Proper Justification

Never Perform Manual Data Corrections Without Justification

Remember: All corrections to GMP data must be explained, signed, dated, and reviewed — never make undocumented changes.

Why This Matters in GMP

In regulated environments, every data entry is subject to traceability and verification. Manual corrections without justification raise serious concerns about data falsification, poor documentation culture, or concealment of deviations. Even if the correction is innocent, its lack of explanation undermines the credibility of the record. GMP relies on the ALCOA+ principles — data must be attributable, legible, contemporaneous, original, and accurate. Manual changes without comments violate these tenets and can invalidate entire records. Whether it’s a batch record, logbook, or test report, improper corrections may compromise decision-making and delay product release or trigger audits and investigations.

Also Read: Never Use Trial Batches for Commercial Release Under GMP

Regulatory and Compliance Implications

FDA 21 CFR Part 211.192 and 211.68 require that records be reviewed and corrected in a documented, traceable manner. WHO GMP and Schedule M emphasize that corrections must not obscure original entries and must be justified. EU GMP requires a clear audit trail for any data changes. Regulatory agencies view unannotated corrections as red flags for fraud or poor documentation practices. Auditors check whether corrections were signed, explained, and approved by QA. Repeated violations may lead to warning letters, import bans, or site shutdowns due to compromised data integrity.

Implementation Best Practices

Use a single line to strike through incorrect entries, never erasing or overwriting them.
Write the correct value next to the original, followed by initials, date, and a brief reason.
Train staff on ALCOA+ principles and visual examples of correct vs. incorrect corrections.
Audit records routinely for unauthorized s and follow up with deviation reports.
In electronic systems, use audit trails and e-signatures with documented change controls.

Also Read: The Future of MHRA GMP Regulations and Their Impact on Pharma Manufacturing

Regulatory References

FDA 21 CFR Part 211.192 – Production Record Review
FDA 21 CFR Part 211.68 – Automatic, Mechanical, and Electronic Equipment
WHO GMP – Documentation and Data Integrity Guidance
EU GMP Annex 11 – Computerized Systems
Schedule M – Good Documentation Practices