A GMP record should allow an independent reviewer to reconstruct what was done, by whom, when, with which materials and equipment, what was observed and how exceptions were handled.
Good documentation practice is not handwriting etiquette. It is the operating discipline that turns an activity into reliable evidence and connects decisions to the data available at the time.
1. Record work when it happens
Enter information at the time the activity, observation or decision occurs. If a late entry is unavoidable, record the actual entry date and time, identify when the activity occurred where supported, and explain the delay according to procedure. Never backdate.
- Use permanent, legible entries in designated fields.
- Record actual observations—not expected values.
- Do not pre-sign or pre-complete steps.
- Do not rely on memory or unofficial notes for later reconstruction.
2. Correct transparently
Preserve the original entry. On paper, use a single line through the incorrect information, enter the correction, sign or initial and date it, and document the reason where it is not obvious or procedure requires. Electronic corrections should retain the original value, identity, time and reason through controlled audit trails.
A reviewer should be able to see what was originally recorded, what replaced it, who changed it, when and why.
3. Control forms, worksheets and logbooks
| Control | Purpose |
|---|---|
| Unique form or record identity | Links the entry to the approved version and activity. |
| Issued or reconciled copies | Prevents unofficial duplication and missing records. |
| Numbered logbook pages | Makes removal and replacement visible. |
| Defined blank-field practice | Distinguishes not applicable from forgotten information. |
| Continuation-page linkage | Keeps multi-page records complete and ordered. |
| Retention and retrieval | Preserves evidence for review and inspection. |
Shop-floor and laboratory examples
- Batch record: enter the actual start and finish time for each critical step; do not copy the planned schedule.
- Equipment log: document use, cleaning, status and maintenance chronologically so conflicting activities are visible.
- Temperature record: investigate a missing or abnormal reading; do not draw a smooth line through the gap.
- Laboratory worksheet: retain weights, dilutions, calculations and corrections needed to reproduce the reported result.
- Electronic system: use individual accounts and approved electronic signatures; a paper signature does not repair a shared login.
- Hybrid record: define which paper and electronic elements together form the complete original record.
4. Review for meaning—not signatures alone
A reviewer should evaluate completeness, chronology, calculations, required second checks, unexplained corrections, missing entries, deviations and consistency with source data. Review depth should reflect risk.
- Could the work be reconstructed?
- Are entries plausible and in sequence?
- Do calculations and transcriptions agree with source data?
- Were exceptions escalated and resolved?
- Are related electronic records or audit trails part of the review?
Common documentation mistakes
- Backdating or recording work in advance
- Overwriting, correction fluid or obscuring the original entry
- Using ditto marks where an actual result is required
- Leaving unexplained blank fields
- Using uncontrolled scrap paper or personal spreadsheets
- Signing for work performed by another person
- Recreating a lost record without transparent identification
- Checking presence of signatures without reviewing the underlying evidence
Primary references
Accessed 23 September 2026. Verify current requirements applicable to your products, jurisdiction and approved pharmaceutical quality system.
Educational notice: This article provides general education and does not replace approved procedures, product-specific scientific assessment or regulatory requirements.