This is a ready-to-use person-in-plant visit report form. Replace every <<FILL: ...>> placeholder. Complete it the same day as the visit while details are fresh, distribute per the oversight plan, and file it where the next visit’s report can be compared against it for trend. A filled specimen follows.
Header
| Field | Entry |
|---|---|
| Report number | <<FILL>> |
| Site / CDMO | <<FILL>> |
| Product / campaign | <<FILL>> |
| Batch(es) covered | <<FILL>> |
| Visit date(s) | <<FILL>> |
| PIP name | <<FILL>> |
| Oversight model per plan | <<FILL: on-site / virtual / hybrid>> |
Instructions
Complete every field with a specific entry, not a general impression. A field left as “observed as planned, no issues” carries less decision value than a specific statement of what was checked. Distribute within <<FILL: e.g. 24 hours>> of the visit. Retain per <<FILL: document retention period>>.
Planned versus observed
| Field | Entry |
|---|---|
| Planned | <<FILL: what this visit was scheduled to observe>> |
| Observed | <<FILL: what actually happened, step by step, specific enough to reconstruct>> |
Deviations and events
| Deviation / event number | One-line description | Status |
|---|---|---|
<<FILL>> | <<FILL>> | <<FILL: open / under investigation / closed with disposition>> |
Open items
| Item | Named owner | Due date | Tracker / CAPA reference |
|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
A verbal commitment made by CDMO staff during the visit is recorded here with an owner and due date; it is not a corrective action until it is.
Trend note
<<FILL: how this visit compares to the prior visits in the same campaign or relationship, e.g. "third consecutive batch with no gowning deviations">>
Recommendation
<<FILL: one of: continue as planned / escalate a named concern / increase oversight for the next batch>>
Distribution
| Recipient | Date sent |
|---|---|
| Sponsor technical operations | <<FILL>> |
| Sponsor quality unit | <<FILL>> |
| CDMO site (a form the site can act on) | <<FILL>> |
Filled specimen
The sponsor, CDMO, and product names below are illustrative, not a real CDMO relationship or filing.
| Field | Entry |
|---|---|
| Report number | PIP-2026-0034 |
| Site / CDMO | Meridian Fill Services |
| Product / campaign | Acme Therapeutics monoclonal antibody fill, batch 3 of 4 |
| Visit date | <<FILL: date>> |
| Oversight model | On-site, full campaign (first campaign at this site) |
Planned versus observed: Planned: observe fill line changeover, batches 3 to 4. Observed: changeover 1 per SOP, no deviation; changeover 2, line clearance checklist signed complete before the changeover crew had actually finished clearing the filling line’s tubing set, a gap of approximately five minutes between signature and physical clearance.
Deviations and events: DEV-4471, line clearance signed before physical clearance verified, under investigation.
Open items: Corrective action, a hard stop requiring a second-person verification of clearance before the signature is entered, owner: CDMO Manufacturing Supervisor, due date: before batch 4 changeover, tracker reference: CAPA-2026-0091.
Trend note: First line-clearance timing gap observed in this campaign; no prior comparable finding in the two changeovers preceding this one.
Recommendation: Escalate a named concern. Do not proceed with batch 4’s changeover until the second-person verification step is confirmed in place and demonstrated once under PIP observation.
Common inspection findings this form prevents
- A trip report that only states the visit happened, with no specific, reconstructable detail of what was checked.
- A verbal commitment from CDMO staff that never converts into a tracked item with an owner and a due date.
- No trend comparison across visits, so a recurring issue looks like a series of isolated one-offs.
How to adapt this form
- Set your own distribution timeline and retention period in the instructions.
- Keep the planned-versus-observed field specific; a generic entry defeats the purpose of the form.
- File every completed report where the next visit’s author can review it before writing the trend note.