Do Not Record Test Results Before Completing the Analysis

Record Test Results Only After Full Completion of Analysis

Remember: Entering test results before completing the entire analysis violates data integrity and can mislead quality decisions.

Why This Matters in GMP

Premature documentation of test results is a critical GMP violation. Such entries misrepresent the actual testing process and compromise the accuracy and traceability of data. Incomplete or anticipated results may be incorrect, based on partial data, or conflict with final outcomes. This practice not only undermines the credibility of the lab but may also mask analytical issues. It prevents QA from performing thorough review and interpretation. GMP demands that results be documented only after the analytical procedure has been fully executed, calculations reviewed, and results verified. Jumping ahead to record results early suggests intent to fabricate or circumvent procedures — both serious compliance concerns.

Also Read: Do Not Wear Jewelry or Cosmetics Inside Cleanroom Areas

Regulatory and Compliance Implications

FDA 21 CFR Part 211.194 requires that results be recorded accurately and only after completion. WHO GMP and EU GMP Chapter 6 mandate contemporaneous recording in line with data integrity standards. Schedule M emphasizes that results should be legible, complete, and not based on assumptions. Premature entries may be classified as falsification or manipulation during regulatory inspections. Agencies look for discrepancies between instrument printouts and reported values. Quality systems must ensure that every recorded test result is backed by complete, reviewed, and verified data.

Implementation Best Practices

Train analysts to follow step-by-step completion and documentation protocols.
Incorporate double-check steps where the reviewer verifies test completion before data entry.
Use laboratory information systems (LIMS) that lock result entry until full completion is recorded.
Conduct periodic audits of lab notebooks and test logs for premature entries.
Implement deviation management for any early or out-of-sequence data recording.

Also Read: The Importance of Contract Manufacturing in Ensuring GMP Compliance in Pharma

Regulatory References

FDA 21 CFR Part 211.194 – Laboratory Records
EU GMP Chapter 6 – Quality Control
WHO GMP – Data Integrity in Analytical Testing
Schedule M – Documentation and Recordkeeping