Panel · Use case · Quality
Manufacturing Site Transfer Board.
LiveGo / No-Go BoardIs the receiving site ready to take over supply, and what must be closed before we release the transfer?
Manufacturing Site Transfer Board is a ready-made use case for Quality. It ships under the Go / No-Go Board template.
For quality leads. You get a recommendation, the score matrix and vote tally, the conditions of approval and the dissent record. Claims are cited or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
Is the receiving site ready to take over supply, and what must be closed before we release the transfer?
Who scores
A transfer is released when the receiving site shows it can make the product to the same quality. US rules require changes to an approved application to be reported in a defined way.
| Seat | What it scores | What it works from |
|---|---|---|
| Director Quality Assurance | Whether the site meets the quality agreement and demonstrates comparable product.1 | ICH Q10 and Q12. |
| Regulatory Strategist | Which supplements or variations are required and whether they are approved.2 | 21 CFR 314.70 and regional rules. |
| Clinical Operations Director | Whether clinical supply is protected during the transition. | Supply plans. |
| Global Commercial Compliance Officer | Whether contracts, audit rights and data-integrity commitments are in place. | The quality and supply agreements. |
What the board does
Must-meet gates. Comparable product, approved filings and a signed quality agreement are must-meet. A shortfall on any holds the release.1,2
Conditions with triggers. Open items become conditions with an owner, a date and the consequence, for example hold the release.
Dissent recorded. If a seat would hold the release, the report states what evidence would change its mind.
Recommended length
Standard
Four lenses bear on this decision. Standard depth gives each a seat, with the criteria, the matrix and the conditions in about four pages.
You can pick another length on the form. The other two stay available.
Assumptions the board scores against
The board states the assumptions behind its criteria and says what each gap limits. Examples for this decision:
- The comparability data are complete.
- Regulators will approve the change within the planned time.
- Supply from the sending site continues until release.
Standards, guidance and sources
Frame
The decision practice behind the memo itself is on the template page.
What gets flagged
Any comparability claim not backed by data, any filing assumed approved, and any open quality finding closed by assertion.
What arrives
- The proposal and the decision sought
- Board recommendation
- Criteria and scoring basis
- Seat assessments
- Score matrix and vote tally
- Conditions of approval
- Pre-mortem and rebuttal outcome
- Dissent and what would reverse the call
What it will not do
The decision belongs to the named decider and the seats are AI specialists. The thresholds are set by the proposer or the decider, and the board does not invent them.
It is not a quality audit and does not release product.
It does not decide. The decision belongs to the named human decider, and the seats are AI specialists.
It does not set thresholds or weights for you. The proposer or the decider sets them.
It does not average away a failed must-meet criterion.
References
- [1] International Council for Harmonisation. Quality guidelines, including Q10 and Q12. Known from the ICH listing; the guidelines were not read.
- [2] Code of Federal Regulations. 21 CFR 314.70: Supplements and other changes to an approved NDA. Known from the eCFR; the text was not read in this pass.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Panel service
Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.
To edit a saved template, open New → Panel → From template, or the library rail on the service form.