Requirements for Good Documentation Practice (GDP)

1. Legibility

   • All entries should be clear, readable, and permanent (no pencil or erasable ink).

2. Accuracy

   • Data should reflect the actual observation, measurement, or action without manipulation.

3. Contemporaneous Recording

   • Entries should be made at the time the activity is performed, not afterward.

4. Attributable

   • Every entry must be traceable to the person making it, usually through signatures, initials, or electronic login.

5. Original

   • Data should be recorded directly into controlled documents or authorized formats (not on scrap paper).

6. Complete

   • No information should be omitted; corrections must not obscure the original entry.

7. Consistent

   • Dates, formats, terminologies, and units of measurement should be used consistently.

8. Corrections

   • Errors must be corrected with a single line through the incorrect entry, signed/initialed, dated, and explained if needed (no overwriting).

9. Controlled Documents

   • Use only approved, version-controlled documents; obsolete versions should be withdrawn.

10. Audit Trail

    • For electronic records, there must be a secure and traceable audit trail to capture changes.

11. ALCOA+ Principles

    • Data must be Attributable, Legible, Contemporaneous, Original, Accurate, and also Complete, Consistent, Enduring, Available.

🎓 Discover one of the best Pharmaceutical Quality Assurance course available —click below to explore the course that’s shaping future Quality Assurance skills.

https://trcjw.on-app.in/app/oc/306166/trcjw