Follow
1. Date and time should be recorded in GMP records as mentioned above.
2. Data should be recorded only in the format duly issued and approved by Quality Assurance.
3. Entries in the logbooks should be made in chronological order. Entries should never be pre-completed.
4. Data recording should be done by trained and authorized personnel.
5. Data should be recorded as it is displayed on the respective equipment panel.
6. Unusual observation during the activity should be recorded, signed and dated. Same should be reported to area person-in-charge and QA.
7. If any observation/signature/date are to be repeated, the same should be rewritten. Ditto (—-“—) marking or “as above” or “do” should not be used.
8. Manual entries should be reviewed and signed by the second person for accuracy and completeness.
9. Raw data/printouts generated during the activity should be signed at the left bottom with the date and should be attached to relevant records. Printouts made on the thermal paper should be photocopied. Thermal paper copy along with photocopy should be attached to the concerned record.
