This is a ready-to-use checklist for confirming that every site contributing CMC data to a marketing application, an internal manufacturing site, a clinical manufacturing facility, a contract testing laboratory, or a CDMO, is ready to have its data relied on in the filing. It is distinct from a general pre-approval inspection readiness checklist: this one is scoped to the specific question of whether a given contributing site’s data belongs in the submission at all, and whether the sponsor has actually verified it rather than accepted a summary certificate. Run it per site, well before the target filing date, because a gap found here cannot usually be fixed in the final months. Replace every <<FILL: ...>> placeholder and mark each item Pass, Fail, or N/A with evidence. A filled specimen follows. This is educational reference content, not legal or regulatory advice.
Section A, Site identification and application status
Section B, Pre-submission audit and quality agreement
Section C, Data integrity verification at the site
Section D, Data handoff and ongoing oversight
Acceptance criteria
- Every item is Pass or a justified N/A, or carries a Fail with a named owner and a due date well ahead of the target filing date.
- Section C is backed by the sponsor’s own produced verification evidence for a risk-based sample of the site’s results, not the site’s self-report alone.
- Any known data integrity gap at the site is self-identified with a dated remediation plan, never left to be found by the site’s own audit alone or by an investigator.
- This checklist is completed and Pass for every contributing site before that site’s data is treated as filing-ready.
Signoff
References
21 CFR 211.22, 211.34 (quality unit responsibilities extending to contracted operations).
FDA guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements (Nov 2016, final).
FDA Data Integrity and Compliance With Drug CGMP, Questions and Answers (2018).
21 CFR Part 11 (electronic records and signatures), for the audit trail and access items in Section C.
Confirm the current version of each reference before issue.
Filled specimen
A partial completed checklist for an example contract testing laboratory running stability for a biologic drug product.
Here B2 is the item that matters most: a pre-submission audit happened, which is good, but a High-severity finding from that audit was still open, which means the site was not actually ready even though the audit box was technically checked. D3 is the kind of gap that looks theoretical until a site loses accreditation or closes eighteen months before filing; testing the export now, while there is time, is cheap insurance against something that is very expensive to discover late.
Common inspection findings this checklist prevents
- A site named in the application that was never independently GMP-confirmed by the sponsor.
- A pre-submission audit that happened on schedule but whose findings were never closed before the data was relied on.
- Submission-cited data from a contract site accepted on a summary certificate alone, with no sponsor-side trace to raw data.
- No contingency plan when a contributing site becomes unavailable between the data-generation period and the inspection.
How to adapt this checklist
- Run one copy of this checklist per contributing site, not one combined checklist for the whole program.
- Set the audit and remediation timelines against your actual target filing date; items found late in this checklist are, by definition, found too late to fix comfortably.
- Where a site contributes more than one data type (for example, an API site that also does stability), confirm Section C is completed separately for each data type it generates.
- Feed every Fail into the program’s tracked action list alongside the pre-BLA audit defect log, so site-level gaps and result-level gaps are visible in one place.
- Confirm every regulation in the references against the current published version before issue.
