How to use this document
Copy the template below into your quality system. Replace every <<FILL: ...>> placeholder with your company, system, and process specifics, then route it through your own document control, review, and approval. The filled specimen shows one worked example; adapt the numbers and scope to your operation and verify each cited regulation or standard against the current source before you rely on it.
This is a generic, originally worded starting point. It contains no confidential, proprietary, or employer material, it is drafted with AI assistance and reviewed, it is not legal or compliance advice, and adopting it does not by itself create or prove compliance. See the Disclaimer and Terms.
This is a ready-to-use checklist for deciding whether a technology transfer is actually done, as distinct from technically executed. A transfer with the last batch record signed is not necessarily complete; this checklist tests the seven conditions that define “done” so the gap between the two does not surface later as a finding, a deviation, or a supply interruption. Replace every <<FILL: ...>> placeholder with your own specifics. A worked filled specimen follows.
Checklist
Disposition
Anything short of all seven items passing, or failing with a documented and time-bound remediation plan, is a transfer technically executed but not complete. It will surface later as a finding, a deviation, or a supply interruption, usually at a worse time than now.
Approvals
Filled specimen
Extract from the readiness review for Acme Therapeutics’ ATX-207 lentiviral-vector CAR-T process transfer, ahead of the PPQ readiness decision. Company, product, and numbers are illustrative.
Overall readiness decision: ready to proceed to PPQ. All seven items passed with named evidence; item 5 was marked N/A with a stated reason rather than left blank, which is itself part of what makes this checklist defensible on review.
Common inspection findings this checklist prevents
- A transfer declared complete based on a signed batch record alone, with no check against the full “done” definition.
- Independent operator performance assumed from training records rather than demonstrated and documented.
- A deviation trend reviewed as individual closures with no explicit statement that the pattern, taken together, is not systemic.
- A regulatory filing determination made informally, never confirmed in writing before the readiness decision.
- An item marked Pass with no evidence reference, so the basis for the decision cannot be reconstructed later.
How to adapt this checklist
- Set your document number and link it to the transfer plan and report it closes out.
- Require a named evidence reference for every Pass, not a bare checkmark.
- If any item is N/A, write the reason; an unexplained N/A reads the same as a skipped check to a reviewer.
- Route Fail items to a remediation plan with an owner and due date before signing the overall disposition.
- Do not treat this checklist as a formality run after the PPQ readiness decision is already made informally; it is meant to inform that decision, not rubber-stamp it.
