This is a ready-to-use pre-campaign readiness checklist for a person-in-plant (PIP) assignment. It is the per-campaign go/no-go instrument that operationalizes the risk-based oversight model decision and the standing Person-in-Plant Program SOP; complete it before the PIP’s first day on a new campaign, never retroactively. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
Instructions
Complete every item before the campaign starts. Any item marked No or N/A needs a documented disposition, close the gap, escalate for a risk acceptance, or delay the campaign start, before proceeding; do not proceed on an unresolved No. File the completed checklist with the campaign’s oversight plan.
Section 1: Oversight model decision
| Item | Yes / No / N/A | Evidence / notes |
|---|---|---|
| The oversight model (on-site, virtual, hybrid) is selected against the campaign’s actual risk factors: site maturity, product recoverability, deviation history, unit operation complexity | <<FILL>> | <<FILL>> |
| The decision, and its basis, is documented in the campaign’s oversight plan, not decided informally the morning of the first batch | <<FILL>> | <<FILL>> |
| For a hybrid model, the specific unit operations requiring on-site presence are named, not left to judgment in the moment | <<FILL>> | <<FILL>> |
| For a campaign running more than one shift, the handoff method, overlap window or log-only, is decided and documented before the first shift change | <<FILL>> | <<FILL>> |
Section 2: Authority and access
| Item | Yes / No / N/A | Evidence / notes |
|---|---|---|
| The PIP’s authority to observe, ask questions, and escalate traces to language in the current quality or technical agreement with this CDMO | <<FILL>> | <<FILL>> |
| Badge, site access, or remote-viewing credentials are confirmed and tested before the campaign start date | <<FILL>> | <<FILL>> |
| For virtual oversight, the video feed and electronic batch record access have been tested and work as expected | <<FILL>> | <<FILL>> |
Section 3: Escalation channel
| Item | Yes / No / N/A | Evidence / notes |
|---|---|---|
| The specific individual or role serving as the CDMO’s floor quality representative for this campaign is named, not assumed | <<FILL>> | <<FILL>> |
| The PIP has walked through the escalation channel with the named contact before day one | <<FILL>> | <<FILL>> |
| Expected response times for an escalation are documented and agreed with the CDMO | <<FILL>> | <<FILL>> |
Section 4: PIP qualification
| Item | Yes / No / N/A | Evidence / notes |
|---|---|---|
| Current GMP training is on file for the assigned individual | <<FILL>> | <<FILL>> |
| Product and process knowledge specific to this program is confirmed, master batch record and campaign CPPs/CQAs reviewed | <<FILL>> | <<FILL>> |
| Aseptic or gowning qualification is current, where the campaign involves a sterile operation | <<FILL>> | <<FILL>> |
| Deviation-writing competence has been demonstrated and reviewed | <<FILL>> | <<FILL>> |
| The PIP’s independence and conflict-of-interest disclosure is completed and signed, with any disclosed fact dispositioned by sponsor quality leadership | <<FILL>> | <<FILL>> |
Section 5: Open items carried from the prior campaign
| Item | Yes / No / N/A | Evidence / notes |
|---|---|---|
| Every open finding from the prior campaign at this CDMO has been reviewed and its current status confirmed before this campaign starts | <<FILL>> | <<FILL>> |
| Any active manufacturing change at this site relevant to this product has a documented comparability sampling plan the PIP knows to watch for | <<FILL>> | <<FILL>> |
Sign-off
| Role | Name | Decision | Date |
|---|---|---|---|
| Sponsor technical operations / manufacturing lead | <<FILL>> | <<FILL: go / no-go / go with conditions>> | <<FILL>> |
| Sponsor quality unit | <<FILL>> | <<FILL>> | <<FILL>> |
Filled specimen
Extract for Acme Therapeutics’ third PPQ batch campaign at Meridian Fill Services for ATX-410.
| Item | Entry |
|---|---|
| Oversight model | Hybrid: on-site for fill and stoppering, virtual for the remainder, per the clean deviation trend across the first two PPQ batches |
| Shift handoff method | Not applicable; campaign runs a single day shift only |
| Authority basis | Quality Agreement QA-MER-002, Section 4.3, PIP access and escalation rights |
| Escalation contact | R. Okonkwo, Meridian floor quality lead, confirmed by phone 2026-09-10 |
| PIP qualification | J. Alvarez, GMP training current, gowning qualification current through 2027-01, product knowledge review completed against MBR-ATX410-Rev4 on 2026-09-09 |
| Independence disclosure | Completed 2026-09-09, no disclosed facts, no disposition needed |
| Carried-forward item | CC-2026-014 stopper supplier change remains in effect; comparability sampling at fill and 24-hour hold flagged for this campaign |
| Decision | Go, no conditions. Approved by M. Chen (Technical Operations) and S. Farouk (Quality) 2026-09-11 |
Common findings this checklist prevents
- A PIP dispatched to a campaign with no documented authority basis, discovered only when a floor supervisor questions it mid-campaign.
- An oversight model chosen informally with no traceable risk basis, inconsistent from campaign to campaign at the same site.
- A carried-forward finding from the prior campaign silently dropped because nobody reviewed it before the next campaign began.
- A PIP arriving on site without tested access credentials, losing the first hours of a campaign to logistics instead of oversight.
- A multi-shift campaign starting with no decided handoff method, discovered only after an item falls through the first shift change.
- A PIP assigned with no documented independence or conflict-of-interest disclosure on file for this specific campaign.
How to adapt this checklist
- Add or remove items to match your own quality agreement’s specific PIP provisions.
- Set the sign-off roles to match your own organization’s actual approval chain for campaign-level oversight decisions.
- Link this checklist to your Person-in-Plant Oversight Plan and Program SOP by document number.