This is a ready-to-use readiness checklist to run and sign before opening the first transfer sample. The cheapest transfer failure to avoid is discovering, mid-study, that an instrument was out of calibration or a reference standard had expired. Replace every <<FILL: ...>> placeholder. This content is educational reference, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Transfer protocol number | <<FILL>> |
| Method | <<FILL>> |
| Receiving unit (RU) | <<FILL>> |
| Completed by | <<FILL>> |
| Date | <<FILL>> |
Readiness items
| # | Item | Evidence | Verified (initials/date) |
|---|---|---|---|
| 1 | Instruments qualified and within calibration | IQ/OQ/PQ records, calibration certificates | <<FILL>> |
| 2 | Analysts trained on this method, with documented competency (minimum 2 analysts for the study) | Training records, read-and-understand, qualification run if applicable | <<FILL>> |
| 3 | Reference standard on hand, correct lot, in date, from the same source as SU or bridged | Certificate of analysis, storage record | <<FILL>> |
| 4 | Reagents at the correct grade, in date | Receiving records, grade verification | <<FILL>> |
| 5 | Current controlled method version issued to the RU (not a draft or marked-up copy) | Document control issuance record | <<FILL>> |
| 6 | Samples received with intact chain of custody and documented storage/shipping conditions | Shipping record, temperature log | <<FILL>> |
| 7 | Transfer protocol approved by QA at both sites before this checklist is signed | Signed protocol approval page | <<FILL>> |
| 8 | For a shipped sample: split from a homogeneous lot, with homogeneity confirmed or assumed on a documented basis | Sample preparation / split record | <<FILL>> |
Acceptance criteria
- Every item is verified before the first transfer sample is opened; a Fail on any item pauses the study until resolved.
- Reference standard and reagent lots used are recorded and locked for the duration of the transfer; a mid-study lot change is not permitted without a documented, separately assessed bridging study.
- The protocol approval (item 7) predates this readiness sign-off; readiness confirms execution conditions, it does not substitute for protocol approval.
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| RU technical lead | <<FILL>> | ||
| RU Quality Assurance | <<FILL>> |
References
USP General Chapter <1224>, Transfer of Analytical Procedures. Company analytical instrument qualification and calibration program procedures.
Confirm the current version of each reference before issue.
Filled specimen
A completed readiness checklist for an example transfer. Illustrative only.
| # | Item | Evidence | Verified |
|---|---|---|---|
| 1 | Instruments qualified and within calibration | HPLC-14 calibration cert, valid to 15 Dec 2026 | T. Nwosu, 04 Aug 2026 |
| 2 | Analysts trained (2 analysts) | Training records TR-0812, TR-0813; both read-and-understood method TM-0042 v2.0 | T. Nwosu, 04 Aug 2026 |
| 3 | Reference standard, correct lot, in date | Standard lot RS-2026-07, CoA on file, expires Jan 2027 | T. Nwosu, 04 Aug 2026 |
| 6 | Chain of custody intact | Shipment temperature log: 2-8C maintained throughout, no excursion | T. Nwosu, 04 Aug 2026 |
This is the record that lets a team say, credibly, that a later result difference was not caused by an expired standard or a cold-chain excursion, because both were checked and closed before the study began, not assumed afterward.
Common inspection findings this checklist prevents
- A transfer is run and later found to have used an instrument that was out of calibration at the time.
- A reference standard lot expires mid-study with no bridging assessment, confounding the result.
- Testing begins before the protocol is fully approved by both sites’ QA.
- No documented chain of custody exists for samples shipped between sites, so a shipping excursion cannot be ruled out as the cause of a discrepancy.
How to adapt this checklist
- Set the protocol number, method, and RU in the header.
- Add site- or method-specific readiness items (for example a specific column conditioning step, or a biological reference standard’s activity re-verification).
- Run this checklist as a hard gate before samples are opened, not as a formality completed afterward.
- Confirm every regulation in the references against the current published version before issue.