Tech Transfer
Technology Transfer · technology transfer · tt
The formal handover of a product, process or method from one site / unit to another — the riskiest activity in a pharma network. Governed by ICH Q10 §3.2.3 and WHO TRS 961 Annex 7.
Tech transfer covers R&D → commercial, site → site, contract-mfg outsourcing, method transfer between QC labs, and equipment / platform changes. Failure mode: receiving site can't reproduce sending-site performance because tacit knowledge wasn't captured.
A proper tech-transfer pack includes development history, validated method packages, qualified equipment lists, CPP/CQA matrices, PPQ protocol, training records, and the receiving-site comparability protocol.
V5 supports tech transfer by deep-cloning approved formulas and routings between sites with full diff, and by tracking transfer-batch results against sending-site historicals.
- ICH Q10 §3.2.3
- WHO TRS 961 Annex 7
Free trial, no credit card, onboard in days, not months.