Technology Transfer Protocol
A sending-unit to receiving-unit technology transfer protocol covering the transfer of product and process knowledge, analytical methods, and acceptance criteria, with a gap analysis and a transfer report structure. Aligned to WHO TRS 961 Annex 7 and the lifecycle knowledge-management expectations of ICH Q10 and Q12.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
The protocol that turns a handover into a controlled exercise with acceptance criteria — what knowledge moves, what the receiving unit must demonstrate, and what counts as transferred. Transfers fail on the knowledge nobody wrote down: the operator adjustment, the undocumented hold time, the method quirk only the sending analyst knew. Whether the receiving unit has met the criteria is a decision your quality units make jointly, not a milestone the schedule declares.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
WHO TRS 961 Annex 7 sets out the principles and documentation expected in pharmaceutical technology transfer, including the sending and receiving unit responsibilities. ICH Q10 makes knowledge management a pharmaceutical quality system enabler, and ICH Q12 frames the lifecycle change management a transfer usually triggers. None of them defines your acceptance criteria, your run counts, or when the receiving site is ready to release commercially. Your two quality units decide that jointly; the protocol here is SPEQ synthesis structured to record the decision.