This is a ready-to-use running log for tracking PPQ slot readiness at a contract development and manufacturing organization (CDMO), from the date the slot is booked through the date batch one actually starts. Its purpose is narrow: catch a slot-versus-readiness conflict, transfer, comparability, materials, or facility fit still open as the date approaches, early enough that moving the slot is still a real option, not a decision made for you by the calendar. Replace every <<FILL: ...>> placeholder with your own specifics. A worked filled specimen follows.
Document control header
| Field | Entry |
|---|---|
| Document title | CDMO PPQ Slot Readiness Log for <<FILL: product / process>> |
| Document number | <<FILL: e.g. LOG-PPQ-SLOT-002>> |
| CDMO site | <<FILL>> |
| Booked PPQ slot date | <<FILL>> |
| Log owner | <<FILL: e.g. CDMO relationship owner / person-in-plant lead>> |
1. Purpose
This log records the status of the four CDMO logistics prerequisites, transfer report closure, site comparability, raw material release, and facility fit, at defined checkpoints between slot booking and batch one, so any gap is visible with enough schedule margin remaining to move the slot rather than run PPQ against an unresolved gap.
2. Scope
| Dimension | Decision |
|---|---|
| Product / process in scope | <<FILL>> |
| CDMO site and slot in scope | <<FILL>> |
| Checkpoint frequency | <<FILL: e.g. weekly, or biweekly until 4 weeks out, then weekly>> |
| Out of scope | <<FILL: e.g. the PPQ protocol's own technical content, covered separately>> |
3. Responsibilities
| Role | Responsibility |
|---|---|
| CDMO relationship owner / person-in-plant lead | Owns this log, updates it at each checkpoint, escalates a gap the moment it is identified, not at the next scheduled checkpoint |
| Validation lead | Reviews the log at each checkpoint against the PPQ readiness checklist; confirms the slot decision logic (close, move, or document) is actually followed |
| Quality Assurance | Reviewer of record for any entry disposed as a documented risk acceptance |
4. Field definitions
| Field | Format | Required | Who completes it | When |
|---|---|---|---|---|
| Checkpoint date | DD-MMM-YYYY | Yes | Log owner | Each checkpoint per section 2 |
| Days to booked slot | Integer | Yes | Log owner | Each checkpoint |
| Transfer report status | Open / Approved | Yes | CDMO relationship owner | Each checkpoint |
| Comparability status | Not started / In progress / Established with data | Yes | Technical lead | Each checkpoint |
| Material release status, by material | Not released / Released, margin days | Yes | Supply chain / CMC | Each checkpoint |
| Facility fit status | Open action(s) / Closed | Yes | CDMO relationship owner | Each checkpoint |
| Overall status | Green (all four closed) / Yellow (open, margin remains) / Red (open, no margin) | Yes | Log owner | Each checkpoint |
| Action if Yellow or Red | Free text | If not Green | Log owner + Validation lead | Same checkpoint |
5. Log
| Checkpoint date | Days to slot | Transfer report | Comparability | Material release | Facility fit | Overall | Action |
|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
6. Escalation rule
Any checkpoint scoring Red triggers a decision within <<FILL: e.g. 2 business days>>: move the slot, or document a formal risk acceptance signed by Quality Assurance before the slot date. A Red status with no recorded decision by the next checkpoint is itself an escalation to <<FILL: e.g. site head / program leadership>>.
7. Retention
This log is retained as part of the PPQ campaign’s readiness evidence, per <<FILL: your document retention policy / QMS reference>>, and referenced by document number in the PPQ Readiness Review Checklist’s CDMO logistics rows.
8. References
See the paired article, PPQ readiness: the prerequisites that decide success before batch one, for the reasoning behind the four-check logistics gate. See the paired PPQ Readiness Review Checklist for how this log’s status feeds the overall readiness disposition.
Filled specimen
Extract for an example cell therapy drug product transferring into a CDMO fill-finish suite. Company and product are illustrative.
| Checkpoint date | Days to slot | Transfer report | Comparability | Material release | Facility fit | Overall | Action |
|---|---|---|---|---|---|---|---|
| 2026-07-14 | 42 | Open, expected 2026-07-25 | In progress | Cryobag lot not yet released, 8-week lead time | Open (isolator qualification pending) | Red | Escalated to program leadership; slot-move option opened with CDMO scheduling same day |
| 2026-07-28 | 28 | Approved 2026-07-24 | Established with data, SCR-011 | Cryobag lot released, 4 weeks margin | Isolator qualification closed 2026-07-26 | Green | None; continue routine checkpoints |
| 2026-08-18 | 7 | Approved | Established | Released, margin holding | Closed | Green | None |
The 2026-07-14 entry is the example this log exists for: two open logistics items with real margin remaining, caught at a checkpoint rather than discovered the week of batch one. Because the gap surfaced 42 days out, the team had a genuine choice, and in this case closed both items rather than moving the slot; the log shows the decision was made with margin, not made for the team by a shrinking calendar.
Common inspection findings this log prevents
- CDMO logistics status relayed verbally between program updates, with no dated record of when each check actually closed.
- A facility-fit or material-release gap discovered only in the week before batch one, with no evidence it was tracked earlier.
- A Red-status gap with no recorded decision, silently carried into the PPQ campaign.
How to adapt this log
- Set your checkpoint frequency in section 2 to match how far out the slot is booked; a slot booked six months out needs a longer runway of checkpoints than one booked six weeks out.
- Name a single log owner in the header; a log nobody is accountable for updating does not get updated.
- Keep the escalation rule in section 6 specific about who gets escalated to and within what timeframe; a vague escalation rule does not actually escalate.
- Cross-reference this log’s document number in the PPQ Readiness Review Checklist’s CDMO logistics rows so a reviewer can trace from the checklist back to the full history.