This is a ready-to-use technology transfer plan for moving a process, method, or product from a sending site to a receiving site, internal or contract manufacturer. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal document control, review, and approval. A worked filled specimen follows the template. Verify each cited reference against the current source before you rely on it.
Document control header
| Field | Entry |
|---|---|
| Document title | Technology Transfer Plan for <<FILL: product / process>> |
| Document number | <<FILL: e.g. TTP-2026-05>> |
| Version | <<FILL>> |
| Effective date | <<FILL>> |
| Sending site | <<FILL>> |
| Receiving site | <<FILL: internal or CDMO>> |
| Plan owner | <<FILL: e.g. Tech Transfer Lead>> |
| Linked risk assessment | <<FILL: RA-ID>> |
1. Purpose
This plan defines how <<FILL: product / process>> transfers from the sending site to the receiving site so the receiving site can manufacture, test, or both, to the same quality standard and the same understanding of what is critical and why. It sets the team, the deliverables, the process and analytical transfer approach, the engineering run strategy, and the criteria that decide when transfer is complete.
2. Scope
| Dimension | Decision |
|---|---|
| Sending site | <<FILL: site, department, process owner>> |
| Receiving site | <<FILL: site; first product transferred there?>> |
| Product / process in scope | <<FILL: unit operations covered>> |
| Analytical methods in scope | <<FILL: list, or reference the transfer protocol>> |
| Transfer type | <<FILL: like-for-like / scale change / equipment change / site-to-CDMO>> |
| Out of scope | <<FILL>> |
State whether this is like-for-like or changes scale, equipment, or site. Each changed variable is a risk carried into risk assessment <<FILL: RA-ID>>; this plan executes against that analysis.
3. Transfer team and RACI
| Activity | Sending site | Receiving site | QA | Regulatory |
|---|---|---|---|---|
| Process description and knowledge package | A/R | C | I | I |
| Analytical method transfer protocol and report | C | A/R | C | I |
| Facility, equipment, and scale risk assessment | C | C | A/R | I |
| Engineering run protocol and execution | C | A/R | C | I |
| PPQ readiness decision | C | C | A | C |
| Regulatory filing impact assessment | I | I | C | A/R |
R = responsible, A = accountable, C = consulted, I = informed. Name one accountable owner per row, plus the transfer lead and process, analytical, validation, and QA leads for both sites, in the plan’s execution log; a shared “A” is not accountability.
4. Deliverables
| # | Deliverable | Owner |
|---|---|---|
| 1 | Process description and knowledge transfer package | <<FILL>> |
| 2 | Technology transfer risk assessment | <<FILL>> |
| 3 | Facility and equipment equivalence assessment | <<FILL>> |
| 4 | Analytical method transfer protocol and report | <<FILL>> |
| 5 | Engineering run protocol(s) and report(s) | <<FILL>> |
| 6 | Technology transfer summary report | <<FILL>> |
Each deliverable needs a named owner and a tracked status; “in progress” with no owner is not a status.
5. Process description transfer
Package what the receiving site needs to run the process as understood, not just as written: the approved process description and master recipe, the CPPs and CQAs with their basis, known process sensitivities and prior deviations, and knowledge that lives with people rather than documents. Hold a structured knowledge transfer session, not just a document handoff, and record the questions raised and answered.
6. Analytical method transfer linkage
Every test method the receiving site will run transfers under its own protocol per USP <1224>. State which option applies to each method and why; this plan tracks analytical transfer as a linked deliverable and does not restate acceptance criteria, which live in that protocol. Engineering runs do not start until the methods needed to test them are transferred or bridged.
| Option | When it fits |
|---|---|
| Comparative testing | Default for most assays and impurity methods; both labs test the same samples against predefined criteria |
| Co-validation | Method validation and the transfer are happening in the same window; receiving lab generates part of the original validation data |
| Revalidation (full or partial) | Comparative testing is impractical, or the method or receiving platform changed materially |
| Transfer waiver | Receiving site already runs this exact method, unmodified, on equivalent instrumentation, with a documented rationale on file |
| Method | Option selected | Rationale |
|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> |
<<FILL>> | <<FILL>> | <<FILL>> |
7. Engineering run strategy
| Field | Entry |
|---|---|
| Number of runs and purpose | <<FILL: e.g. 2; equipment fit, then repeatability and training>> |
| Batch scale | <<FILL: commercial scale? if not, state the bridging rationale>> |
| Data collected | <<FILL: CPPs, CQAs, in-process data, yield, cycle time>> |
| Success criteria per run | <<FILL>> |
| Disposition of material | Not for commercial release |
Engineering runs are not qualification batches; they find equipment, procedure, and operator gaps before a PPQ batch is committed. A gap found here is cheap; the same gap found in PPQ is expensive and may force a repeat.
8. Success criteria and completion
Transfer is complete only when every deliverable in section 4 is approved, analytical methods are transferred with a closed report, engineering run data shows the process performs against the carried-over CPPs and CQAs, open deviations are closed or carry a documented rationale, and the receiving quality unit formally accepts the process. Record the decision in the summary report.
9. Timeline and gates
| Gate | Milestone | Target | Actual |
|---|---|---|---|
| G1 | Risk assessment and knowledge transfer complete | <<FILL>> | <<FILL>> |
| G2 | Analytical method transfer report approved | <<FILL>> | <<FILL>> |
| G3 | Engineering run(s) executed and reviewed | <<FILL>> | <<FILL>> |
| G4 | PPQ readiness decision | <<FILL>> | <<FILL>> |
Each gate needs a documented go decision before the next stage starts. Do not begin engineering runs before G1 and G2 close; a run against an unassessed risk or an unqualified method produces data nobody can defend.
10. References
ICH Q10, Pharmaceutical Quality System (knowledge management and technology transfer). WHO Technical Report Series 961, Annex 7, WHO Guidelines on Transfer of Technology in Pharmaceutical Manufacturing. FDA guidance, “Process Validation: General Principles and Practices” (January 2011). ICH Q9, Quality Risk Management.
Confirm the current version of each reference before issue.
11. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
12. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (Transfer lead) | <<FILL>> | ||
| Sending site process owner | <<FILL>> | ||
| Receiving site process owner | <<FILL>> | ||
| Approver (QA) | <<FILL>> |
Filled specimen
The plan completed for an example small-molecule tablet transferring from an internal development site to a contract manufacturer. Company, product, and numbers are illustrative.
| Field | Entry |
|---|---|
| Product / process | Acme Therapeutics, ATX-101 10 mg tablets, wet granulation and compression |
| Sending site | Acme Therapeutics Pilot Plant, Site A |
| Receiving site | Contract manufacturer Site B, first Acme product there |
| Transfer type | Site-to-CDMO, scale change from 25 kg to 150 kg |
Two engineering runs were planned: run 1 for equipment fit at the new scale, run 2 for repeatability and operator training, both against the CPP ranges and CQA criteria used at Site A, with the scale-change rationale documented in risk assessment RA-2026-014. Run 1 showed a tablet hardness trend near the lower CQA limit, traced to a compression force setpoint difference from the scale-up model, corrected before run 2, which passed within the full CPP and CQA ranges. The transfer was not declared complete until the corrected setpoint was written into the Site B master recipe and the summary report captured the deviation and its resolution.
| Gate | Milestone | Target | Actual |
|---|---|---|---|
| G1 | Risk assessment and knowledge transfer complete | Week 4 | Week 4 |
| G2 | Analytical method transfer report approved | Week 8 | Week 9, one week slip; the HPLC assay comparative testing was repeated after a system suitability failure on the first attempt |
| G3 | Engineering runs executed and reviewed | Week 14 | Week 16; run 1’s hardness deviation pushed run 2 back two weeks while the compression force setpoint was corrected |
| G4 | PPQ readiness decision | Week 18 | Week 19 |
The gate structure caught a scale-up problem in an engineering run, where it was cheap to fix, rather than in a PPQ batch. That is the sequence a reviewer expects: knowledge transferred, methods bridged, the process proven at the new site before qualification is committed. Note what the actual column shows and what it does not: two gates slipped, and each slip has a one-line, traceable reason tied to a real deviation, not a schedule note saying “delayed.” A reviewer reading only the actual dates would flag a slip; reading the reason next to it is what makes the slip defensible instead of concerning.
Common inspection findings this plan prevents
- A transfer with no documented plan, so process understanding cannot be reconstructed.
- Analytical methods used to release engineering run or PPQ batches before the transfer report is approved.
- Engineering runs at a different scale or equipment than commercial, with no bridging rationale.
- A transfer declared complete with open deviations and no documented justification.
- No single accountable owner, so gaps surface at PPQ instead of during transfer.
How to adapt this plan
- Set your document number, sites, and linked risk assessment number in the header.
- Build the RACI in section 3 from your organization; keep one accountable owner per activity.
- Size section 4 to your transfer type; a like-for-like transfer needs less than a scale change or first-time CDMO transfer.
- Set the number and purpose of engineering runs in section 7 from the risk assessment, not habit.
- Confirm every reference in section 10 against the current published version before issue.