This is a ready-to-use checklist for a Pre-Approval Inspection, the inspection FDA runs against a new or supplemental drug application under Compliance Program 7346.832. A PAI has four stated objectives: readiness for commercial manufacturing, conformance to the application, a data integrity audit of the records that support the application, and commitment to quality in pharmaceutical development. This checklist is organized around those four, plus inspection logistics, so a team can confirm each one is genuinely met, not just documented. Replace every <<FILL: ...>> placeholder, run it well before the anticipated inspection window, and treat every “No” as an action with an owner and a date. A filled specimen follows. This content is educational reference, not legal or regulatory advice; adapt it to your product and quality system, and verify each cited regulation against the current source before you rely on it.
Header
| Field | Entry |
|---|---|
| Checklist number | <<FILL: FORM-ID>> |
| Application | <<FILL: NDA / BLA / ANDA / supplement number>> |
| Product | <<FILL>> |
| Site | <<FILL>> |
| Anticipated inspection window | <<FILL>> |
| Completed by (name, role) | <<FILL>> |
| Date | <<FILL>> |
Mark each item Pass, Fail, or N/A, with evidence and an owner for every Fail.
Section A, Readiness for commercial manufacturing
| # | Item | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|
| A1 | The commercial process is validated (process performance qualification complete) or the validation approach and status are clearly defined | <<FILL>> | <<FILL>> | <<FILL>> |
| A2 | Facilities, utilities, and equipment supporting the product are qualified and in a maintained state | <<FILL>> | ||
| A3 | Analytical methods used for release and stability are validated or verified, and transferred to the QC lab that will run them | <<FILL>> | ||
| A4 | The quality system elements (deviations, CAPA, change control, complaints) are functioning, not just written | <<FILL>> | ||
| A5 | Personnel performing the process and testing are trained and qualified for the commercial product | <<FILL>> | ||
| A6 | Raw material and component controls, including supplier qualification, are in place for commercial supply | <<FILL>> | ||
| A7 | Stability program supporting the proposed shelf life is running per protocol | <<FILL>> |
Section B, Conformance to the application
| # | Item | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|
| B1 | The process as run on the floor matches the process described in the application (batch formula, steps, in-process controls, limits) | <<FILL>> | <<FILL>> | <<FILL>> |
| B2 | Specifications and analytical methods on file match those in the submission | <<FILL>> | ||
| B3 | Equipment and facility described in the application match what is installed | <<FILL>> | ||
| B4 | Any post-submission changes are captured in change control and, where required, reported to the agency | <<FILL>> | ||
| B5 | Batch records for submission and validation batches are complete and reconcile with the data in the application | <<FILL>> | ||
| B6 | Commitments made in the application (for example stability, process monitoring) are being met | <<FILL>> |
Section C, Data integrity of the supporting records
| # | Item | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|
| C1 | The raw data behind every result cited in the application exists, is retained, and can be produced | <<FILL>> | <<FILL>> | <<FILL>> |
| C2 | Instrument audit trails for the submission and validation data are enabled, field-level, and reviewed | <<FILL>> | ||
| C3 | No shared or generic accounts were used to generate or approve submission data; actions are attributable | <<FILL>> | ||
| C4 | Injection sequences and reprocessing history for cited chromatography results reconcile with the reported values, with no unexplained deleted or orphan data | <<FILL>> | ||
| C5 | Cross-references (record time vs instrument log vs signature vs access) for a risk-based sample of key results are consistent | <<FILL>> | ||
| C6 | Any known data integrity gap is self-identified, risk-assessed, and under a dated remediation plan | <<FILL>> | ||
| C7 | System clock control and time synchronization are evidenced for the systems that produced the data | <<FILL>> |
Section D, Commitment to quality in pharmaceutical development
Mandatory on the first PAI for a given product; risk-based on later PAIs (periodic, or triggered by a material change to the quality system, management team, or corporate structure).
| # | Item | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|
| D1 | The pharmaceutical development report for the application product aligns with the site’s broader development program, not written as a one-off for this filing | <<FILL>> | <<FILL>> | <<FILL>> |
| D2 | Roles and responsibilities across development disciplines are documented, and quality assurance has genuine oversight of development, scale-up, and technology transfer, not a sign-off after the fact | <<FILL>> | ||
| D3 | Senior management can describe, specifically, how it ensures product quality during development, not in generic terms | <<FILL>> | ||
| D4 | The development team was genuinely multidisciplinary (process development, engineering, quality, analytical) and cross-functional involvement is evidenced through development, tech transfer, and into commercial manufacturing | <<FILL>> | ||
| D5 | Quality risk management was applied during development to identify high-risk formulation and process variables, with mitigations carried into the control strategy | <<FILL>> |
Section E, Inspection logistics
| # | Item | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|
| E1 | Front room and back room roles are named (coordinator, scribes, SMEs, runner, back room lead) | <<FILL>> | <<FILL>> | <<FILL>> |
| E2 | SMEs for the application’s process and data are prepared and have done a mock interview | <<FILL>> | ||
| E3 | A document request log and two-copy practice are ready | <<FILL>> | ||
| E4 | Leadership escalation and daily-huddle plan are set | <<FILL>> |
Acceptance criteria
- Every item is Pass or a justified N/A, or carries a Fail with a named owner and a due date before the inspection window.
- Section C items are backed by produced evidence, not assertions, for a risk-based sample of the results the application relies on.
- Section D is completed in full for a first PAI on this product; for a later PAI, confirm and document whether Section D coverage is expected this cycle before marking its items N/A.
- Any data integrity gap is self-identified with a dated remediation plan, not left to be found during the inspection.
- The checklist is signed and the open actions are tracked to closure.
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| Inspection readiness lead | <<FILL>> | ||
| Quality Assurance | <<FILL>> | ||
| Site head | <<FILL>> |
References
FD&C Act sections 501, 704; 21 CFR Parts 210, 211, and, for biologics, Part 600. FDA Compliance Program 7346.832 (Pre-Approval Inspections), revised effective 10 August 2026; for CDER-regulated biologics, Compliance Program 7346.832M (Prelicense and Preapproval Inspections), issued 14 April 2026. FDA Data Integrity and Compliance With Drug CGMP, Questions and Answers (2018). 21 CFR Part 11 (electronic records and signatures).
Confirm the current version and clause numbers of each reference before issue.
Filled specimen
A partial completed checklist for an example biologic BLA. Illustrative only.
| # | Item | P/F/NA | Evidence | Owner / due |
|---|---|---|---|---|
| A1 | Commercial process validated (PPQ complete) | Pass | PPQ report VR-2026-014, 3 lots | - |
| B1 | Floor process matches the application | Pass | Line-by-line comparison MFG-COMP-07 | - |
| B5 | Submission/validation batch records reconcile with the application | Fail | Two validation batch records missing a second-person verify signature | J. Okoro, due 30 Aug |
| C1 | Raw data behind cited results exists and is producible | Pass | Sampled 25 results, all traced to raw files | - |
| C6 | Known DI gap self-identified and under remediation | Pass | DI risk register item DI-2026-09, dated plan, 60% complete | D. Shah |
| D3 | Senior management can describe specifically how it ensures quality during development | Fail | Interview showed generic awareness, no specific example of an intervention | VP Quality, due 20 Aug (coaching + mock Q&A before the window) |
Here B5 surfaced a real gap, two validation batch records missing a required verification signature, with an owner and a date before the window. C6 shows the healthy posture: a data integrity gap the site found itself, risk-assessed, and is actively closing, which reads to an investigator as control rather than surprise. D3 is the softer kind of gap Objective 4 tests for: the documents may be in order, but if the executive who will sit for the interview cannot describe a concrete example, the finding is credibility, not paperwork, and it needs rehearsal, not a new procedure.
Common inspection findings this checklist prevents
- The floor process or specifications diverge from what the application describes, and no one reconciled them beforehand.
- Raw data behind a cited result cannot be produced during the inspection.
- Submission data was generated under shared accounts or with audit trails off, so results are not attributable.
- A data integrity gap exists that the site had not identified, so it is discovered by the investigator instead of self-declared with a plan.
- Development history and quality risk management exist on paper but no one, senior management included, can speak to them credibly in an interview, the Objective 4 finding that paperwork alone does not prevent.
How to adapt this checklist
- Set your application, product, and site in the header.
- Add product-specific items (for example sterility assurance for a sterile product, or chain of identity for a cell therapy) to each section.
- Run it early enough that Section C evidence gathering and any remediation can complete before the window.
- Confirm with regulatory affairs whether this is the initial PAI for the product (Section D fully in scope) or a later one, and if later, whether risk factors put Section D back in scope this cycle.
- Feed every Fail into a tracked action list with owners and dates.
- Confirm every regulation in the references against the current published version before issue.