Products continue to be manufactured and used after an evaluation is completed. In ATDS, tiptop proposes a Product Evidence Passport to connect material origins, finished-product batches, use conditions and results, so that the original basis remains traceable when later changes occur.
Record the pathway from origin to outcome
The framework proposes a continuous record: donor provenance, cell bank, production batch, raw-material batch and finished-product batch; formulation and packaging versions; storage and mixing methods; actual dose and conditions of use; and finally the evaluation subject, endpoints, time points and results.
Consent, ethics, biosafety, process deviations and change history also belong in the relevant records. We want this pathway to retain the process through which a product was made, rather than just a final results table.
What the evidence passport is intended to contain
| Section | Proposed records |
|---|---|
| Identity and provenance | Material identity, origins and batch chain |
| Product version | Final formulation, packaging and critical-process versions |
| Actual use | Storage, mixing, dispensing, dose and frequency |
| Evaluation design | Test subject or population, comparison conditions, endpoints, timing and methods |
| Results and changes | Results, deviations, limitations and subsequent changes |
| Continuing management | ERL, corresponding statements, market differences, adverse events and review records |
This is the record structure we propose. The contents and public scope of individual product passports will be presented according to the actual information available.
Retain a basis for judging changes
Source studies document the scientific background, raw-material information identifies materials, and finished-product evaluations document final-product performance. We keep these records in their respective places and link them, making it possible to check which conclusions remain applicable when a product changes.
For example, a packaging or critical-process change should prompt a comparison between the original test sample and the current product before deciding where additional evaluation is needed. Records of scientific advisors, suppliers and strategic partnerships also help trace the path of collaboration.
We propose the evidence passport to bring an individual study into long-term product management. The complete framework is available in ATDS 2026.