Form: IMP Drug Accountability and Reconciliation Log

This is a ready-to-use accountability and reconciliation log for investigational medicinal product. Clinical supply is a closed-loop accountable system: every unit must be accounted for, and inspectors add up accountability columns. If the line does not reconcile, you have an investigation. Replace <<FILL: ...>> placeholders, adopt the field definitions, and keep the log current, not reconstructed at end of trial. A filled specimen row follows. Verify each cited regulation against the current source before you rely on it.

Control header

The reconciliation equation

For every batch and, where applicable, every depot and site:

Manufactured (or received) = Dispensed + Returned + Retained samples + Destroyed + Remaining stock

Any imbalance is investigated: a lost shipment, an unrecorded dispensing, a counting error, or a mislabelled unit. Destruction does not happen until reconciliation is complete, so the evidence is preserved.

Field definitions

Instructions

1. Record every movement as it happens; do not reconstruct the log at end of trial.
2. At each reconciliation, confirm the equation balances for each batch and location.
3. If it does not balance, open an investigation and record the reference; do not close the period until resolved or justified.
4. Assess any in-transit temperature excursion for impact on the IMP before the affected units are used.
5. Authorise and document destruction (often by the sponsor) only after reconciliation is complete.
6. Keep reference and retention samples per the required period so any later question about a batch can be investigated.

Accountability table

Acceptance criteria

• The reconciliation equation balances for every batch and location, or an open investigation is recorded.
• Movements are recorded contemporaneously, not reconstructed.
• Destruction follows, not precedes, reconciliation.
• In-transit temperature excursions are assessed before affected units are used.
• Retention samples are held per the required period.

References

EudraLex Volume 4 Annex 13 (Manufacture of Investigational Medicinal Products), accountability and reconciliation expectations. ICH E6 Good Clinical Practice for site drug accountability. Related reading: GMP for investigational medicinal products, cold-chain shipping qualification.

Confirm the current version and clause numbers of each reference before issue.

Revision history

Filled specimen

The following shows one reconciled batch line, so you can see how the equation reads. The values are illustrative.

In this example the batch reconciles exactly: 1,200 manufactured equal 980 dispensed plus 150 returned plus 20 retained samples plus 50 destroyed, with no remaining stock. Had the line come to 1,190, the missing 10 kits would trigger an investigation, a lost shipment, an unrecorded dispensing, or a counting error, before the period closed. The 50 destroyed were destroyed only after the reconciliation confirmed the numbers, so the evidence survived until the count was proven.

Common inspection findings this log prevents

• Accountability that does not reconcile, with no investigation.
• Destruction before reconciliation, destroying the evidence.
• The log reconstructed at end of trial rather than kept current.
• Returns redispensed without a controlled process.
• In-transit temperature excursions not assessed for impact.

How to adapt this log

1. Set your document number, trial number, and reconciliation frequency in the header.
2. Choose the granularity (batch, depot, site, or subject/kit) your trial needs.
3. Record every movement as it happens.
4. Wire the discrepancy field to your deviation/investigation process.
5. Confirm every regulation against the current published version before issue.