Never Rely on Memory to Record GMP Observations or Results

Document Observations Immediately—Don’t Rely on Memory

Remember: All GMP observations and results must be recorded contemporaneously—memory is not a valid data source.

Why This Matters in GMP

In GMP environments, every observation, measurement, or deviation must be documented at the time it occurs. Delayed entries risk inaccuracies, falsification, and incomplete traceability. Relying on memory compromises data integrity and creates the potential for manipulated results. Human error and recall bias make memory unreliable for regulatory records. Documentation based on recollection is often unverifiable and non-compliant with ALCOA+ principles. Contemporaneous recording ensures accountability, enables effective investigations, and supports product release decisions. It also serves as a strong defense during audits and legal evaluations, proving that processes were followed as prescribed.

Also Read: How Lean Manufacturing Can Help Meet Regulatory Expectations in GMP

Regulatory and Compliance Implications

FDA 21 CFR Part 211.100 and 211.68 mandate that data entries be accurate, attributable, and contemporaneous. WHO GMP and Schedule M reinforce real-time documentation as a core GMP requirement. EU GMP Chapter 4 expects that all entries be traceable and time-stamped. Regulatory authorities view retroactive data entry as a major integrity breach, potentially leading to Form 483s or warning letters. Data must reflect the actual time, conditions, and person performing the activity—not an estimate or assumption. Deviations due to undocumented or late-recorded observations are frequently cited during audits.

Implementation Best Practices

Use preformatted GMP notebooks or e-records with time-stamp functions for real-time documentation.
Train staff on ALCOA+ and emphasize the risk of undocumented operations.
Implement documentation checkpoints during process walks and QA audits.
Discourage post-shift or batch-end entries and review logs for signs of retroactive recording.
Maintain clear SOPs specifying that data must be recorded immediately at the time of observation.

Also Read: GMP for Clinical Trials: Ensuring Proper Packaging and Labeling of IMPs

Regulatory References

FDA 21 CFR Part 211.100 – Written Procedures; Deviations
FDA 21 CFR Part 211.68 – Electronic Records and Data Input
EU GMP Chapter 4 – Documentation
WHO GMP – Data Integrity and Documentation
Schedule M – Good Documentation Practices