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 risk assessment for confirming that a CDMO’s biosafety classification, institutional review, and containment and segregation posture actually fit the specific vector platform and scale in scope, rather than the modality in general. 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 confirms that <<FILL: CDMO / site>> holds a biosafety classification, institutional review, and containment and segregation posture appropriate to <<FILL: vector platform>> at <<FILL: intended manufacturing scale>>, and documents any gap and its disposition before the technical assessment closes.
2. Scope
3. Responsibilities
4. Methodology
Score each factor below against direct, cited evidence, a copy of the institutional review record, the containment procedure, or the authorization certificate, not a verbal assurance. A factor with no evidence behind it is scored as a gap, not as passing.
5. Biosafety classification and institutional review
6. Regulatory contained-use authorization (EU sites)
7. Segregation and waste inactivation
8. Findings and disposition
9. Residual risk statement
<<FILL: state plainly whether the residual risk after all dispositions above is acceptable to proceed, and what would change that conclusion (e.g. a scale change, a new construct)>>
10. References
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
EU contained-use directive framework for genetically modified micro-organisms.
ICH Q9(R1), Quality Risk Management.
Confirm the current version of each reference before issue.
11. Revision history
12. Approvals
Filled specimen
Extract for an example lentiviral vector CDMO assessment. Company, site, and specifics are illustrative.
Finding: institutional biosafety review and the EU contained-use authorization are both scoped to the modality generally, not to this construct at this scale. Disposition: require a process-specific and scale-specific biosafety committee review and a copy of the pending contained-use authorization before the first GMP batch; owner CDMO biosafety contact, target date set 60 days ahead of the planned engineering run. Residual risk: not acceptable to proceed to PPQ until both close; acceptable to proceed with early engineering activities under the site’s existing BSL-2 containment practice while remediation is tracked.
Common inspection findings this assessment prevents
- A biosafety classification claimed at the modality level with no process-specific or scale-specific institutional review behind it.
- A contained-use authorization assumed to cover a construct or scale it was never actually issued for.
- Segregation described as “handled” with no documented, traceable waste-inactivation procedure.
- A gap identified during diligence but never routed to a named owner with a target date.
How to adapt this assessment
- Set your document number, vector platform, and scale in the header.
- Populate sections 5 through 7 from direct evidence, a copy of the review record or authorization, not a verbal claim.
- Score every factor with no evidence as a gap, and route every gap through section 8 with a real owner and date.
- State the residual risk conclusion in section 9 in language a reviewer can evaluate independently, and set a trigger for reassessment if scale or construct changes.
