Do Not Include Unrelated Documents in GMP Production Records

Keep Production Records Free of Unrelated Documents

Remember: Only include relevant, approved documents in GMP production records to preserve clarity and compliance.

Why This Matters in GMP

GMP documentation must be organized, traceable, and limited to approved content. Inserting unrelated notes, calculations, or non-referenced documents into batch records can lead to misinterpretation, loss of traceability, or regulatory observations. Such documents may be unapproved, outdated, or inconsistent with validated processes. Including them may confuse reviewers, interfere with decision-making, or complicate investigations. Regulatory agencies expect batch records to reflect only the data directly associated with the batch. Allowing unrelated documents into the record undermines document control and weakens the reliability of the entire manufacturing process. Maintaining a clean and structured document flow ensures consistency and accountability throughout the production lifecycle.

Also Read: How WHO GMP Guidelines Support the Manufacture of Orphan Drugs

Regulatory and Compliance Implications

FDA 21 CFR Part 211.180 and 211.188 mandate accurate, complete, and traceable production documentation. EU GMP Chapter 4 and WHO GMP stress that documents must be reviewed, approved, and version-controlled. Schedule M emphasizes that production records should contain only approved formats and authorized entries. The inclusion of extraneous documents is often cited during audits as poor documentation control. It raises concerns about unauthorized instructions, deviation concealment, or tampering. Auditors evaluate whether the record clearly shows what happened, by whom, and when — with no ambiguity. Maintaining clean, compliant records is essential for batch approval and GMP inspection readiness.

Also Read: The Relationship Between cGMP and Global Pharmaceutical Standards

Implementation Best Practices

Train personnel on document segregation and the importance of excluding unrelated papers from BMRs.
Designate separate holding areas for reference notes and internal communication that are not GMP-controlled.
Include document control checks in QA line clearance and record reviews.
Use checklists to ensure that only required documents are attached or filed with batch records.
Discard or archive any non-GMP documents as per SOP before batch record submission to QA.

Regulatory References

FDA 21 CFR Part 211.180 – General Requirements
FDA 21 CFR Part 211.188 – Batch Production and Control Records
EU GMP Chapter 4 – Documentation
WHO GMP – Documentation Standards
Schedule M – Documentation and Record Keeping

Also Read: Conduct Periodic Pest Control Audits in GMP Storage Areas