CDMO-to-CDMO Transfer Handoff Checklist

Document type	Checklist
Topic area	Tech Transfer & NPI
Level	Advanced
Updated	October 2026

This is a ready-to-use checklist for a second transfer: a commercial, already-validated process moving from its current manufacturing site, usually a CDMO that has run it for years, to a different contract site. A second transfer is not a repeat of the original transfer with a new site name. The current site’s Continued Process Verification trends, accumulated change history, and operating tribal knowledge all live at that site, not at the sponsor, and the commercial relationship driving the move may be ending on terms that reduce the departing site’s incentive to cooperate. This checklist covers the handoff items a second transfer needs on top of the standard technology transfer plan, gap assessment, risk assessment, and report; run it alongside those documents, not instead of them. Replace every <<FILL: ...>> placeholder with your own specifics. A worked filled specimen follows.

Document control header

Field	Entry
Document title	CDMO-to-CDMO Transfer Handoff Checklist for `<<FILL: product / process>>`
Document number	`<<FILL>>`
Version	`<<FILL>>`
Effective date	`<<FILL>>`
Departing (current) site	`<<FILL>>`
Receiving (new) site	`<<FILL>>`
Linked technology transfer plan	`<<FILL: TTP-ID>>`
Reviewer	`<<FILL>>`

Checklist

#	Item	Evidence	Pass / Fail / N/A
1	Cumulative change control history at the departing site has been reconciled against the sponsor’s own technical file, with every approved change since the original transfer or product launch accounted for	`<<FILL: reference reconciliation record, change log extract>>`	`<<FILL>>`
2	The gap assessment for this transfer compares the new site against the departing site’s actual current process, not against the original sending site’s process description from the first transfer	`<<FILL: reference gap assessment>>`	`<<FILL>>`
3	The comparability basis for this transfer is scored against the departing site’s actual Continued Process Verification trend data, not the original process characterization ranges	`<<FILL: reference CPV trend summary>>`	`<<FILL>>`
4	Contractual rights to the departing site’s batch records, deviation history, and process know-how are confirmed in writing, secured while the commercial relationship remains active rather than assumed available after notice of termination	`<<FILL: reference contract clause, data-rights amendment>>`	`<<FILL>>`
5	The new site’s platform experience with this specific modality, not biologics experience generally, has been independently verified against its actual batch count and deviation history on this modality	`<<FILL: reference platform-experience verification record>>`	`<<FILL>>`
6	Tribal-knowledge capture, interviews, video, or shadowing, from the departing site’s personnel is scheduled while the relationship remains cooperative, not deferred until access to those people is reduced	`<<FILL: reference tribal-knowledge capture log>>`	`<<FILL>>`
7	The quality agreement amendment reflecting the new site’s responsibilities is drafted and routed for co-signature, tracked as its own deliverable rather than an assumed side effect of the transfer report	`<<FILL: reference quality agreement amendment>>`	`<<FILL>>`
8	The regulatory filing sequence adding the new site and removing the departing site is planned with a defined overlap or bridging period, not a single assumed handoff date	`<<FILL: reference regulatory filing plan>>`	`<<FILL>>`
9	Supply continuity risk during the transition, safety stock, allocation, batch scheduling across both sites, has a named owner and a documented plan independent of the technical transfer activities	`<<FILL: reference supply continuity plan>>`	`<<FILL>>`

Disposition

Field	Entry
All items Pass or justified N/A	Yes / No
Items Fail, with remediation plan	`<<FILL: list, owner, due date>>`
Overall handoff readiness decision	Ready to proceed with the technology transfer plan / Not ready, remediation in progress
Decided by (Quality, name, date)	`<<FILL>>`

A second transfer that clears the standard technology transfer completion checklist while any item above remains unresolved is a transfer that was scoped against a process description, a comparability basis, or a contractual position that has already drifted from reality. Anything short of all nine items passing, or failing with a documented and time-bound remediation plan, stays open before the gap assessment and risk assessment that drive the rest of the transfer are finalized.

Approvals

Role	Name	Signature	Date
Sponsor transfer lead	`<<FILL>>`
Receiving site process owner	`<<FILL>>`
Approver (QA)	`<<FILL>>`

Filled specimen

Extract from the handoff checklist for Acme Therapeutics’ ATX-207, a commercial lentiviral-vector CAR-T product, moving from CDMO A, the site that has manufactured it commercially for four years, to CDMO B, for capacity reasons rather than any quality concern. Company, product, and numbers are illustrative.

#	Item	Evidence	Pass / Fail / N/A
1	Change history reconciled against the sponsor’s technical file	Reconciliation record REC-2026-014 found one unreconciled change: a pre-filtration step requalified from 0.45 to 0.22 micron under CDMO A’s internal change control two years into commercial manufacturing, filed as a notification but never folded into the sponsor’s working process description	Fail, remediated: technical file corrected, gap assessment updated before issue
2	Gap assessment compares CDMO B against CDMO A’s actual current process	Gap assessment TTGA-2026-031, built from the corrected technical file reflecting the 0.22 micron filter	Pass
3	Comparability scored against CPV trends, not characterization ranges	CPV trend summary CPV-ATX207-2026-Q3 used as the comparability baseline for titer and potency	Pass
4	Contractual data and know-how rights confirmed	Data-rights amendment executed with CDMO A six months before the planned transition, while the relationship remained active	Pass
5	CDMO B’s platform experience independently verified	CDMO B has run four other sponsors’ CAR-T programs; batch count and deviation history for lentiviral vector handling reviewed and found adequate	Pass
6	Tribal-knowledge capture scheduled while cooperative	Structured interviews with three CDMO A process owners completed; one scheduled shadowing session pending	Fail, remediation: shadowing session rescheduled before the engineering run, owner named, two-week due date
7	Quality agreement amendment drafted and routed	Amendment QA-AMD-2026-009 drafted, naming CDMO B for batch release and in-process testing; awaiting CDMO B co-signature	Fail, remediation: co-signature tracked as its own item, due before the engineering run
8	Filing sequence planned with an overlap period	Regulatory confirmed a Prior Approval Supplement adding CDMO B, with CDMO A remaining on the license through a six-month overlap	Pass
9	Supply continuity plan owned	Supply chain lead named owner of a documented allocation plan across both sites through the transition	Pass

Overall handoff readiness decision: not ready, remediation in progress on items 1 (closed before issue), 6, and 7, each with a named owner and due date. Two of nine items failing at the first review, both with a dated remediation path, is what makes this checklist useful: it caught the filter specification drift and the pending quality agreement signature before either reached the gap assessment or the engineering run, not after.

Common inspection findings this checklist prevents

A gap assessment built against the original transfer’s process description rather than the departing site’s actual current process, missing a change made under that site’s own change control.
A comparability package scored against wide, original characterization ranges when the process’s real, current control limits, reflected in CPV trend data, are tighter.
A sponsor unable to produce the departing site’s batch records or deviation history because data and know-how rights were never confirmed in writing before the relationship ended.
A receiving site’s platform experience assumed from its general biologics track record, with no independent check of its actual batch count and deviation history on this specific modality.
A quality agreement still naming the departing site for a function the new site now performs, with the transfer report’s approval mistaken for closing that question.
A filing sequence assumed to be a single clean handoff date, with no planned overlap, creating a supply gap when the timelines do not line up exactly.

How to adapt this checklist

Set your document number and link it to the technology transfer plan this handoff checklist supports.
Require a named evidence reference for every Pass, and a dated remediation owner for every Fail, before the gap assessment and risk assessment driving the rest of the transfer are finalized.
Run item 1, the change-history reconciliation, first; its findings feed directly into the gap assessment and can change the master production instructions the receiving site is working from.
Start item 4, the contractual data-rights confirmation, as early in the relationship’s wind-down as possible, ideally before either party has formally signaled the relationship is ending.
Treat item 7, the quality agreement amendment, as a tracked deliverable with its own due date, not an assumed side effect of the technology transfer report’s approval.