This is a ready-to-use triage form for deciding, ahead of a Pre-Approval Inspection, which of the five Objective 1 sub-objectives under FDA Compliance Program 7346.832 (revised 29 June 2026, implemented 10 August 2026) are likely in scope, so the back room stages the right evidence instead of everything. Sub-objectives 1a and 1e are covered on every PAI; 1b, 1c, and 1d are risk-based. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is educational reference to help a team prepare; it does not predict or control what FDA’s own risk assessment will actually cover, and it is not legal or regulatory advice.
Form control
| Field | Entry |
|---|---|
| Application | <<FILL: NDA / BLA / ANDA / supplement number>> |
| Product and site | <<FILL>> |
| Completed by | <<FILL>> |
| Date | <<FILL>> |
| Anticipated inspection window | <<FILL>> |
Sub-objective 1a: manufacturing and laboratory readiness (mandatory, every PAI)
Covers capabilities, changes, deviations, and trends relating to development of the drug substance and drug product.
| Item to stage | Owner | Ready (Y/N) |
|---|---|---|
| Manufacturing and laboratory capability summary for the commercial process | <<FILL>> | <<FILL>> |
| Recent change control and deviation trend summary for the product | <<FILL>> | <<FILL>> |
| SMEs for process development and technical services briefed | <<FILL>> | <<FILL>> |
Sub-objective 1b: sampling, testing, and supplier qualification (risk-based)
| Trigger present | Y/N | Evidence |
|---|---|---|
| The application assessment identified issues in sampling, testing, or supplier qualification | <<FILL>> | <<FILL>> |
| A previous inspection or remote regulatory assessment identified issues in this area | <<FILL>> | <<FILL>> |
If any trigger is Y, stage: supplier qualification files for critical materials, the sampling plan rationale, and the release-testing SME. If all triggers are N, note the basis for treating 1b as lower priority and revisit if new information emerges before the window.
Sub-objective 1c: facility and equipment controls against contamination (risk-based)
| Trigger present | Y/N | Evidence |
|---|---|---|
| Facility has never been inspected | <<FILL>> | <<FILL>> |
| A new building has been added and not yet inspected | <<FILL>> | <<FILL>> |
| Equipment is new or not covered on a prior inspection | <<FILL>> | <<FILL>> |
| Facility has undergone major changes since the last inspection | <<FILL>> | <<FILL>> |
| Product requires special containment or separation | <<FILL>> | <<FILL>> |
| Application assessment or prior facility information flagged this area | <<FILL>> | <<FILL>> |
If any trigger is Y, stage: facility and equipment qualification packages, the contamination control strategy, and the facilities/engineering SME. If all triggers are N, note the basis and stage a lighter, summary-level packet.
Sub-objective 1d: batch release, change management, and investigations (risk-based)
| Trigger present | Y/N | Evidence |
|---|---|---|
| No history of prior coverage of these elements | <<FILL>> | <<FILL>> |
| The quality system has changed since the last inspection | <<FILL>> | <<FILL>> |
| Prior facility information flagged deficiencies here | <<FILL>> | <<FILL>> |
If any trigger is Y, stage: batch disposition records, change control and CAPA files, complaint and adverse-event handling records, and the Field Alert Report log with the QA disposition SME. If all triggers are N, note the basis for a lighter staging.
Sub-objective 1e: feasibility and justification of the commercial process (mandatory, every PAI, depth varies)
| Item to stage | Owner | Ready (Y/N) |
|---|---|---|
| Process validation status and reports for the commercial process | <<FILL>> | <<FILL>> |
| Scientific justification for processing parameters and control measures in the batch record | <<FILL>> | <<FILL>> |
| Process validation SME briefed, including any application-assessment issues raised | <<FILL>> | <<FILL>> |
Objectives 2 through 4 (covered separately)
Objective 2 (Conformance to Application) and Objective 3 (Data Integrity Audit) are covered on every PAI regardless of the Objective 1 triage above; stage per the PAI readiness checklist. Objective 4 (Commitment to Quality in Pharmaceutical Development) is mandatory on the initial PAI for the product and risk-based afterward; confirm with regulatory affairs which applies before finalizing staging.
Triage summary and sign-off
| Sub-objective | In scope (Y/N/uncertain) | Staging priority |
|---|---|---|
| 1a | Y (mandatory) | <<FILL>> |
| 1b | <<FILL>> | <<FILL>> |
| 1c | <<FILL>> | <<FILL>> |
| 1d | <<FILL>> | <<FILL>> |
| 1e | Y (mandatory) | <<FILL>> |
| Role | Name | Signature | Date |
|---|---|---|---|
| Inspection readiness lead | <<FILL>> | ||
| Quality Assurance | <<FILL>> |
References
FDA Compliance Program 7346.832, Preapproval Inspections, revised 29 June 2026, implemented 10 August 2026, Objective 1 coverage table. For CDER-regulated biologics, Compliance Program 7346.832M, Prelicense and Preapproval Inspections, issued 14 April 2026. FD&C Act sections 501, 704; 21 CFR Parts 210, 211, and, for biologics, Part 600.
Confirm the current version of the compliance program and its coverage criteria against the FDA-published document before relying on this form; FDA revises compliance programs periodically and the specific triggers may change.
Filled specimen
A completed triage for an example supplemental NDA at a site with one prior FDA inspection.
| Sub-objective | In scope | Basis |
|---|---|---|
| 1a | Y, mandatory | - |
| 1b | N | No issues flagged in the application assessment; prior inspection had no findings in sampling or supplier qualification |
| 1c | Y | New filling suite installed since the last inspection, never inspected |
| 1d | Y | Quality system changed: new electronic batch record system implemented since the last inspection |
| 1e | Y, mandatory, moderate depth | PPQ complete, no application-assessment issues raised on the process description |
This specimen shows the point of the triage: the site correctly deprioritized 1b, where nothing changed and no issue was flagged, and concentrated back room staging on 1c (a genuinely new, never-inspected filling suite) and 1d (a new electronic batch record system, the kind of quality-system change the trigger criteria specifically call out). That is a more efficient use of a short preparation window than treating all five sub-objectives as equally likely.
Common inspection findings this form prevents
- Back room staging spread evenly across every possible topic, leaving the genuinely likely areas under-prepared relative to the unlikely ones.
- A new or never-inspected facility element (1c) discovered as a live topic with no qualification package staged and ready.
- A quality-system change since the last inspection (1d, for example a new electronic system) that no one flagged as a likely inspection focus.
- Treating remote interactive evaluations or records requests as lower-stakes than an on-site PAI, when the 2026 compliance program gives them equal standing for meeting these same objectives.
How to adapt this form
- Set the application, product, and site in the control block.
- Work through each trigger table with the people who actually know the site’s inspection history and recent changes, not from memory alone.
- Where a trigger is uncertain, mark it uncertain rather than guessing N, and revisit as more information becomes available before the window.
- Feed the triage summary directly into back room document staging and SME scheduling.
- Confirm the compliance program’s current coverage criteria against the FDA-published document before relying on this form for a real inspection.