Step 1 · Analyze
Batch record omission — “# of needles” left blank for Rotor 5 / Tube 5
During execution of MBR-000112 (G0131 Two Step Iodixanol Purification) for sublot G0131A0226B0AB, the “# of needles” field in Step 9.47, Table 13 (Rotor 5 Concentrate Harvest and Dilution) was left blank for Rotor 5 / Tube 5. The entry was not made contemporaneously, so the batch record carries no documented evidence of how many needles were used. Occurred 24APR2026; identified 30JUN2026 during QA review of the executed batch record.
G0131A0226B0AB
67 days
24 APR 2026 → 30 JUN 2026
QA batch-record review
67 days after execution
The question that decides this case
Impact is reported as two verdicts and never collapsed into one.
TS-000149 identifies harvest volume as a Non-Key Process Parameter; needle count is not a CPP, KPP or CIPC, and harvest volume met target specification. TS-000149
SOP-QM-GEN-000004 requires entries to be complete, accurate and contemporaneous per ALCOA++; SOP-PR-GEN-000007 §5.9.2 requires contemporaneous completion. SOP-QM-GEN-000004
A data-completeness and traceability gap that could delay reconstruction of the activity during batch review, investigation or inspection. DEV-02514 narrative