This is a ready-to-use register for tracking batches from quarantine through disposition. Its two jobs are to make sure no batch sits undispositioned and forgotten, and to give management a real disposition-timeliness metric. A batch aging in quarantine for weeks is not a neutral state; it usually means an investigation has slipped, and it is both an inventory and a data-integrity signal. Replace every <<FILL: ...>> placeholder. A filled specimen row set follows. This is general guidance to adapt, not legal or regulatory advice.
Purpose
Maintain a single, current record of every batch awaiting or completing disposition, so that quarantine aging is visible, disposition timeliness is measurable, and no batch is released without a signed decision or left to age silently. The register feeds the quality metrics program and management review.
How to use this log
- Add a row the moment a batch enters quarantine (production complete or material received).
- Update the row at each state change; never overwrite, append status with date.
- Calculate days in quarantine as (disposition date, or today if still open) minus quarantine start date.
- Flag any open batch past the escalation trigger and route per the escalation column.
- Review the open rows at the defined cadence (for example, weekly) and report aging at management review.
Field definitions
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| Batch / lot number | text | Yes | QA | On entering quarantine |
| Product / strength | text | Yes | QA | On entry |
| Quarantine start date | date | Yes | QA | On entry |
| Target disposition date | date | Yes | QA | On entry, from committed timeframe |
| Blocking item | text | Yes if open | QA | On entry and update |
| Current status | Quarantine / On hold / Released / Rejected | Yes | QA | Each change |
| Disposition date | date | Yes at close | Disposition authority | At decision |
| Days in quarantine | number | Yes | QA (calculated) | Each review |
| Past escalation trigger | Yes / No | Yes | QA | Each review |
| Escalation action | text | Yes if flagged | QA / management | When flagged |
| Disposition authority | name | Yes at close | Disposition authority | At decision |
The register
| Batch | Product / strength | Quarantine start | Target date | Blocking item | Status | Disposition date | Days in QT | Past trigger | Escalation action | Authority |
|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Instructions and thresholds
- Set the target disposition timeframe from your committed lead time (for example,
<<FILL: N>>working days from all testing complete). - Set the escalation trigger (for example, any batch open past target, or open more than
<<FILL: N>>days) and the escalation path (quality management notified, root-cause of the delay recorded). - Distinguish aging caused by an open investigation (quality signal) from aging caused by a testing backlog (capacity signal); both belong in the metric but drive different actions.
Retention
Retain the register and its dated entries per your records retention schedule, for not less than <<FILL: retention period, aligned to batch record retention>>. The register is a GMP record; entries are contemporaneous and are not deleted or overwritten.
Metric derived from this log
- Disposition timeliness: percentage of batches dispositioned within the target timeframe over the period.
- Aging quarantine: count and age of batches open past the trigger at period end.
- Report both at management review; a rising aging count is an early warning that investigations or testing are slipping.
Acceptance criteria
The register is sound when every batch appears from quarantine entry to disposition, days-in-quarantine is current at each review, every batch past the trigger carries an escalation action, and no released batch appears without a disposition date and named authority.
Filled specimen
The following shows an illustrative set of rows at a weekly review. Numbers are illustrative.
| Batch | Product / strength | Quarantine start | Target date | Blocking item | Status | Disposition date | Days in QT | Past trigger | Escalation action | Authority |
|---|---|---|---|---|---|---|---|---|---|---|
| B-4402 | Injection 10 mg/mL | 17 Jul 2026 | 24 Jul 2026 | none, in review | Released | 20 Jul 2026 | 3 | No | none | R. Gomez |
| T-9043 | Tablet 25 mg | 18 Jul 2026 | 25 Jul 2026 | DEV-0177 impact assessment | Released | 20 Jul 2026 | 2 | No | none | R. Gomez |
| S-3310 | Sterile powder | 02 Jul 2026 | 09 Jul 2026 | OOS-0088 investigation open | On hold | 22 | Yes | Quality mgmt notified 10 Jul; delay root cause: repeat sterility per protocol | open | |
| C-1204 | Cell therapy dose | 21 Jul 2026 | 22 Jul 2026 | rapid-sterility pending, short shelf life | Quarantine | 3 | No | tracked on short-shelf-life pathway | open |
Row S-3310 is the point of the register: a batch open 22 days, past its 7-day target, flagged, with the delay reason recorded (an open OOS driving a repeat sterility test). Without the register it would age invisibly; with it, management sees the aging and the cause at the weekly review.
Common inspection findings this log prevents
- Batches sitting undispositioned for long periods with no visibility or escalation.
- A released batch with no traceable disposition decision or named authority.
- Disposition timeliness asserted at management review with no underlying data.
- Aging driven by an open investigation never surfaced as a quality signal.
How to adapt this log
- Set your target timeframe and escalation trigger to your committed lead times.
- Split the register by site or product line if volume warrants, keeping one consolidated view for management review.
- Where an electronic quality system holds this data, configure the same fields and the same aging report rather than keeping a parallel spreadsheet.
- Align the retention period to your batch record retention.