How to use this document
Copy the template below into your quality system. Replace every <<FILL: ...>> placeholder with your company, system, and process specifics, then route it through your own document control, review, and approval. The filled specimen shows one worked example; adapt the numbers and scope to your operation and verify each cited regulation or standard against the current source before you rely on it.
This is a generic, originally worded starting point. It contains no confidential, proprietary, or employer material, it is drafted with AI assistance and reviewed, it is not legal or compliance advice, and adopting it does not by itself create or prove compliance. See the Disclaimer and Terms.
This is a ready-to-use gap assessment for a technology transfer: a factual, side-by-side comparison of the sending site’s established state against the receiving site’s actual state, closed with a disposition someone can act on rather than a bare “differs.” Replace every <<FILL: ...>> placeholder with your own specifics and route it through your normal document control, review, and approval. A worked filled specimen follows. Verify each cited reference against the current source before you rely on it.
1. Purpose
This assessment records what actually differs between the sending site and the receiving site, facility, equipment, utilities, personnel qualification, and quality systems, against what the process requires, and closes every difference with a disposition. It is a factual comparison, not a risk score; the technology transfer risk assessment takes these findings as an input and scores what they mean for the process.
2. Scope
3. Responsibilities
4. How to score a disposition
Every row states four things: the factor, the sending-site value, the receiving-site value, and a disposition someone can act on. “Equipment differs” is not a disposition; what someone is going to do about the difference is. A disposition is one of: Equivalent, no action (the difference does not affect the process or product, state why); Closed with action (a defined change, verification, or study closes the gap, name it); Carried to risk assessment (the difference is real and needs formal risk scoring before a disposition can be written); Open, blocking (the gap must close before the engineering run can proceed).
5. Facility comparison
6. Equipment comparison
7. Utilities comparison
8. Personnel qualification comparison
9. Quality systems comparison
10. Closure summary
The engineering run does not start while a row remains open and blocking. A gap assessment with every row marked “equivalent, no action” on a first-time transfer to a new site is itself a finding worth a second look.
11. References
ICH Q9(R1), Quality Risk Management.
ICH Q10, Pharmaceutical Quality System.
WHO Technical Report Series 961, Annex 7, WHO Guidelines on Transfer of Technology in Pharmaceutical Manufacturing.
Confirm the current version of each reference before issue.
12. Revision history
13. Approvals
Filled specimen
Extract from an example transfer of Acme Therapeutics’ ATX-207 lentiviral-vector CAR-T process from a clinical manufacturing site to a CDMO for the pivotal program. Company, product, and numbers are illustrative.
Closure summary: 22 rows assessed, 14 closed equivalent with no action, 5 closed with action verified before the engineering run, 2 carried to the risk assessment (the titer assay platform difference above and a hold-time question on post-thaw processing time), 1 open and blocking (a final utility qualification report pending at the time of this extract). The assessment was not declared closed, and the engineering run was not scheduled, until that one open row closed.
Common inspection findings this gap assessment prevents
- A gap assessment that lists differences with no disposition, so nobody can show what was actually done about them.
- “Equivalent, no action” used as a default answer rather than a genuine, stated comparison.
- A real difference, especially in analytical instrumentation or reference materials, never carried into the risk assessment that should score it.
- An engineering run started while a blocking row is still open.
- Personnel qualification asserted as complete with no evidence of demonstrated independent performance.
How to adapt this assessment
- Set your document number, sites, and linked risk assessment number in the header.
- Walk every factor in sections 5 through 9 against actual current records or an on-site visit, not memory or the sending site’s original qualification package.
- Write a real disposition for every row; ban “TBD” and “differs” as final entries.
- Carry any row scoring above your organization’s risk threshold into the linked risk assessment by reference number.
- Do not release the engineering run protocol until every blocking row in section 10 is closed.
