This is a ready-to-use standard operating procedure for a sponsor’s person-in-plant (PIP) program. It governs how the role is staffed, how a PIP conducts and documents a visit, and how findings move to verified closure. It is the standing procedure behind the Person-in-Plant Oversight Plan, which scopes a specific campaign; this SOP is the program-level document that applies across every campaign the program covers. Replace every <<FILL: ...>> placeholder, route it through document control, and train every PIP against it before their first assignment. A filled specimen follows.
Document control header
| Field | Entry |
|---|---|
| Document title | Person-in-Plant Program SOP |
| Document number | <<FILL: e.g. SOP-QA-0142>> |
| Version | <<FILL>> |
| Effective date | <<FILL>> |
| Supersedes | <<FILL: prior version or "None, initial issue">> |
| Owner | <<FILL: e.g. Head of Technical Operations>> |
| Applies to | <<FILL: all sponsor personnel assigned as person-in-plant at any contract manufacturer>> |
1. Purpose
This SOP defines how the sponsor staffs, trains, deploys, and documents a person-in-plant (PIP) program at a contract manufacturer, so that real-time floor observations reach a documented, trackable finding and, where warranted, a verified corrective action, rather than remaining an informal impression that leaves no record.
2. Scope
This SOP applies to every PIP assignment at every contract development and manufacturing organization (CDMO) the sponsor uses, whether the model for a given campaign is on-site, virtual, or hybrid. It does not grant a PIP authority to direct CDMO operators, sign batch records, or release product; that accountability remains with the CDMO’s own quality unit under the governing quality agreement. It does not replace a GMP quality audit, which follows its own procedure.
3. Responsibilities
| Role | Responsibility |
|---|---|
| Person-in-plant (PIP) | Observes, verifies against the plan, documents contemporaneously, escalates through the agreed channel, writes fact not opinion; completes a visit report per section 6 for every assignment and a handoff log at every shift change |
| Sponsor quality leadership | Dispositions independence and conflict-of-interest disclosures per section 5.1 step 6, independent of technical operations; owns this SOP; reviews PIP reports; maintains the oversight tracker for findings the CDMO’s own system does not expose to the sponsor; verifies closure per section 8 |
| Sponsor technical operations / manufacturing lead | Selects the oversight model (on-site, virtual, hybrid) per campaign per the risk basis in the linked oversight plan; confirms PIP qualification before assignment |
| CDMO floor quality representative | Receives PIP escalations in real time per the quality agreement; opens the deviation in the CDMO’s own system |
| Training function | Maintains PIP qualification records per section 5 and confirms currency before each new assignment |
4. Definitions
| Term | Definition |
|---|---|
| Person-in-plant (PIP) | A sponsor representative present, physically or virtually, at a contract manufacturer during a defined manufacturing campaign or critical activity, to observe execution in real time |
| Contemporaneous documentation | A record made at the time an event occurs, not reconstructed afterward from memory |
| Closure as claimed | A corrective action marked complete on the strength of a stated commitment or a training record, without confirmation the underlying problem stopped recurring |
| Verified closure | A corrective action confirmed effective because the next relevant occurrence, the next excursion, the next changeover, shows the correct outcome without the PIP needing to prompt it again |
| Escalation channel | The specific individual or role, named in the quality or technical agreement, to whom a PIP raises an observation for floor-level action |
| Independence | The absence of a prior employment, personal, financial, or reporting-line relationship with the CDMO being observed that could reasonably affect what a PIP chooses to write down |
| Shift handoff | The structured transfer of batch status, open items, and unlogged commitments from an outgoing PIP to an incoming PIP at a shift change, confirmed by signature before coverage transfers |
5. Procedure
5.1 Qualifying a PIP before assignment
- Confirm the candidate holds current GMP training, including
<<FILL: 21 CFR 211 fundamentals or the applicable regional equivalent>>, on file with the training function. - Confirm product and process knowledge specific to the program: the candidate has reviewed the master batch record, the process description, and the campaign’s critical process parameters and critical quality attributes before the assignment.
- Where the campaign involves an aseptic or sterile operation, confirm site-specific gowning qualification or a documented equivalent accepted by the CDMO.
- Confirm the candidate has demonstrated deviation-writing competence, evidenced by sample write-ups reviewed against
<<FILL: the sponsor's deviation-writing quality bar or reference examples>>. - Walk the candidate through the specific escalation channel for this CDMO and this campaign before the first day of on-site or virtual presence.
- Complete the PIP Independence and Conflict of Interest Disclosure before assignment; route any disqualifying disclosure to sponsor quality leadership for reassignment, never to a waiver.
- Document qualification against this checklist in the training record before the assignment begins; do not assign an unqualified individual regardless of schedule pressure.
5.2 Preparing for a campaign
- Confirm the campaign’s oversight model, on-site, virtual, or hybrid, and its basis, against the linked Person-in-Plant Oversight Plan.
- Confirm the PIP’s access, badge, or remote-viewing credentials are arranged with the CDMO before the campaign start date.
- Confirm the escalation channel’s specific contact and, for virtual oversight, the video feed and electronic batch record access are tested before the first batch.
- For a campaign running more than one shift, confirm the handoff method, overlap window or log-only, before the first shift change, per section 5.3 step 15.
5.3 During the visit
- Observe against the batch record and campaign plan; do not direct operators, touch product or equipment, or countermand the CDMO’s own quality assurance function.
- Document every observation contemporaneously, planned versus observed, in the PIP Visit and Trip Report, the same day, never reconstructed later from memory.
- Escalate any finding through the agreed channel, the CDMO’s floor quality representative or line supervisor, never directly to the operator, the moment it is identified.
- At every shift change, complete the PIP Shift Handoff and Continuity Log; the incoming PIP reviews and signs it before assuming coverage.
- For a manufacturing change in effect during this campaign, verify the change was implemented as the approved change control describes and that any comparability sampling the change control specifies was executed at the correct steps.
5.4 After the visit
- Complete and distribute the visit report the same day per section 6.
- Enter every open finding into the PIP Observation and CAPA Escalation Log with a named owner and due date, whether in the CDMO’s own CAPA system or the sponsor’s own tracker.
- Track every entry to verified closure per section 8; do not close an entry on a stated commitment alone.
6. Visit reporting
Every PIP assignment produces a completed PIP Visit and Trip Report the same day as the visit, distributed to sponsor technical operations and quality leadership and, in a form the CDMO can act on, back to the site. A report exists to carry decision value, not to prove the visit happened; a generic entry with no specific deviation reference or trend note does not meet this SOP’s bar.
7. Acceptance criteria
A PIP assignment meets this SOP’s bar when: the assigned individual was qualified per section 5.1 before the assignment began; every observation was documented the same day; every finding reached the CDMO’s CAPA system or the sponsor’s oversight tracker with a named owner and due date; and no finding was closed without verification per section 8.
8. Closure verification
A finding closes only when the next relevant occurrence confirms the corrective action worked, not when a training record or a stated commitment is filed. A finding that recurs after being marked closed is reopened, not logged as a new, unrelated finding, so the recurrence is visible in the trend.
9. Records generated
| Record | Retention | Location |
|---|---|---|
| PIP qualification record | <<FILL: e.g. life of the individual's assignment plus 2 years>> | <<FILL: training system>> |
| PIP Independence and Conflict of Interest Disclosure | <<FILL: matches the qualification record retention period>> | <<FILL: training system>> |
| PIP Visit and Trip Report | <<FILL: matches or exceeds the associated batch record retention period; access limited to sponsor quality and technical operations leadership; subject to legal hold where applicable>> | <<FILL: document management system>> |
| PIP Shift Handoff and Continuity Log | <<FILL: filed with the campaign's visit reports>> | <<FILL: document management system>> |
| PIP Observation and CAPA Escalation Log | <<FILL>> | <<FILL>> |
10. References
FDA guidance, “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (November 2016). ICH Q10, Pharmaceutical Quality System, Section 2.7, Management of Outsourced Activities and Purchased Materials. FDA guidance, “Frequently Asked Questions, Developing Potential Cellular and Gene Therapy Products” (August 2026, docket FDA-2024-D-4311).
Confirm the current version of each reference before issue.
11. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
12. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (Technical Operations) | <<FILL>> | ||
| Reviewer (Quality Assurance) | <<FILL>> | ||
| Approver (Head of Quality) | <<FILL>> |
Filled specimen
Extract for Acme Therapeutics’ PIP program covering its fill-finish CDMO relationship with Meridian Fill Services.
| Field | Entry |
|---|---|
| Document number | SOP-QA-0142, version 2.1 |
| Scope | All Acme personnel assigned as PIP at any CDMO, currently Meridian Fill Services and Beacon Cell Processing |
| Qualification example | J. Alvarez qualified for the ATX-410 fill campaign on 2026-08-11: GMP training current through 2027-03, gowning qualification completed at Meridian’s Suite 3 on 2026-08-05, escalation channel walkthrough with Meridian’s floor quality lead completed 2026-08-10, independence disclosure signed 2026-08-09 with no disqualifying facts |
| Procedure step 16 in practice | During the ATX-410 campaign’s second batch, a change control implementing a new stopper supplier was in effect; the PIP confirmed the comparability sampling plan specified in CC-2026-014 was executed at fill and at 24-hour hold, matching the approved change control exactly |
| Procedure step 15 in practice | The ATX-410 campaign ran two shifts during its harvest step; the day-shift and night-shift PIPs completed a 15-minute phone handoff each shift change, logging one unlogged verbal commitment that the night-shift PIP confirmed closed before batch disposition |
| Closure verification example | An environmental monitoring excursion response-time gap flagged in batch 1 was marked closed after retraining; verified closed only after batch 3’s excursion showed the correct response time on the first try |
Common inspection findings this SOP prevents
- A PIP assigned to a campaign with no documented qualification record on file, staffed on availability alone.
- A PIP assigned with no documented independence or conflict-of-interest screening on file.
- Observations made but never entered into a trackable CAPA or quality system, existing only in an unfiled trip report.
- A finding closed on a stated commitment, with no confirmation the next relevant event actually went correctly.
- No procedure governing what a PIP does when a manufacturing change is in effect during the observed campaign.
- No structured handoff between PIPs on a multi-shift campaign, leaving an open item or verbal commitment to disappear between shifts.
- Escalation channels that exist informally between two individuals with nothing written into a governing procedure.
How to adapt this SOP
- Set your document number, owner, and applies-to scope in the header.
- Confirm the qualification elements in section 5.1 match your own training system’s actual records, not an aspirational list.
- Point every cross-reference to your own quality agreement, deviation SOP, and CAPA system by name and document number.
- Set real retention periods in section 9 that match your document management system’s actual configuration.
- Confirm every reference in section 10 against the current published version before issue.