PIP Regulatory Inspection Support Checklist

Document type	Checklist
Topic area	Tech Transfer & NPI
Level	Advanced
Updated	September 2026

This is a ready-to-use checklist defining what a person-in-plant (PIP) does, and does not do, if a health authority inspector arrives at the CDMO during an assignment. Complete Section 1 before any campaign begins, as part of standing PIP program setup; it does not wait for an inspection to become likely. Section 2 is the in-the-moment reference the PIP carries during an active assignment. Replace every <<FILL: ...>> placeholder. A filled specimen follows.

Instructions

Section 1 is a one-time-per-CDMO-relationship setup, reviewed at the standing quality agreement’s normal review cadence. Section 2 is checked, not completed from scratch, the moment an inspector is confirmed on site. File the completed checklist with the CDMO’s quality agreement documentation.

Section 1: Pre-established authority and contacts

Item	Confirmed	Evidence / notes
The quality or technical agreement with this CDMO states whether a sponsor PIP may be present in an inspection room during a health authority inspection	`<<FILL>>`	`<<FILL>>`
The agreement states how, if at all, the PIP is introduced to an inspector	`<<FILL>>`	`<<FILL>>`
A named sponsor regulatory affairs contact is identified in advance to field any sponsor-specific question an inspector raises	`<<FILL: name, role, direct contact method>>`	`<<FILL>>`
The CDMO’s standard inspection host role or title is identified, so the PIP knows who to defer to on arrival	`<<FILL>>`	`<<FILL>>`
Every PIP assigned to this CDMO has been walked through Section 2 of this checklist before their first assignment	`<<FILL>>`	`<<FILL>>`

Section 2: If an inspector arrives during your assignment

Step	Action
1	Do not initiate contact with the inspector. Identify yourself to the CDMO’s inspection host and confirm whether your continued presence on the floor is acceptable to the CDMO during the inspection.
2	If asked directly by the inspector who you are, state your role and employer factually and briefly. Do not characterize the CDMO’s performance, volunteer an opinion, or speculate about the inspection’s scope.
3	If asked a question about the sponsor’s own specification, filing, or process rationale, do not answer from memory. State that you will refer the question, and immediately notify the named sponsor regulatory affairs contact from Section 1.
4	If a document you happen to hold a personal copy of is requested, direct the request to the CDMO’s document control function for the official record; do not hand over your own copy directly.
5	Document, in real time, which records were requested, which questions were asked, and any verbal commitment CDMO staff made that touches the sponsor’s product.
6	Notify sponsor quality and regulatory affairs leadership the same day, not at the next scheduled call, of anything logged in step 5.
7	Complete the standard visit report with the three inspection-specific fields added: sponsor-specific observations, CDMO commitments to track, and any apparent contradiction with the sponsor’s current approved specification or filing.

Sign-off (Section 1, per CDMO relationship)

Role	Name	Date
Sponsor technical operations / manufacturing lead	`<<FILL>>`	`<<FILL>>`
Sponsor regulatory affairs	`<<FILL>>`	`<<FILL>>`
Sponsor quality unit	`<<FILL>>`	`<<FILL>>`

Filled specimen

Extract for Acme Therapeutics’ PIP program at Meridian Fill Services, covering an unannounced FDA surveillance inspection during the ATX-410 PPQ campaign.

Section 1 item	Entry
Agreement provision	Quality Agreement QA-MER-002, Section 7.2: PIP may remain on the floor during an inspection at the CDMO’s discretion; PIP is not introduced to the inspector unless the CDMO’s host chooses to do so
Named regulatory affairs contact	D. Reyes, Director of Regulatory Affairs, mobile line on file with all assigned PIPs
CDMO inspection host	Meridian’s Director of Quality, R. Okonkwo, standing role for any health authority visit

Section 2 event log entry	Detail
Step 1	PIP J. Alvarez confirmed with R. Okonkwo that continued floor presence during the FDA investigator’s visit on 2026-09-18 was acceptable
Step 3	Investigator asked why the PPQ batch count for ATX-410 was two rather than three; PIP referred the question, did not answer, and called D. Reyes within ten minutes
Step 5 to 6	Investigator requested the environmental monitoring trend for the fill suite; Meridian’s host committed to providing a written excursion-response SOP update within 30 days; logged and relayed to sponsor quality and regulatory affairs the same afternoon
Step 7 outcome	Visit report flagged the batch-count question and the 30-day SOP commitment as tracked items; no contradiction found between Meridian’s response and Acme’s filed S.2.5 narrative

Common findings this checklist prevents

A PIP answering a sponsor-specific regulatory question directly, without the sponsor’s own regulatory affairs function ever being looped in, creating a statement inconsistent with the filed application.
No one at the sponsor learning about a CDMO’s verbal commitment to an inspector until the next scheduled business review, long after the commitment’s due date has passed.
A PIP handing over a personal working copy of a document instead of directing the request through the CDMO’s own document control, creating an uncontrolled copy in the inspection record.
Confusion on the floor, in front of the inspector, about who is authorized to speak for the sponsor, because it was never decided before the inspection happened.

How to adapt this checklist

Confirm the inspection-presence and introduction provisions actually exist in your own quality or technical agreement; if they do not, add them at the next agreement review rather than discovering the gap during a live inspection.
Set your own named regulatory affairs contact and confirm every assigned PIP has that contact’s direct line, not just a general department number.
Walk every newly assigned PIP through Section 2 as part of standard qualification, before their first assignment, not only after an inspection has already happened once.