This is a ready-to-use narrative report for closing out a CDMO technical assessment. It is not the scorecard and it is not the disposition register; both of those are structured for lookup, scored sections, a row per finding, and neither is written to be read start to finish. This report is the short, connected account of what was assessed, what was found, and what is recommended, built so an executive sponsor, a regulatory lead, or a future reviewer can read the whole thing in a few minutes and understand why the decision came out the way it did. Replace every <<FILL: ...>> placeholder with your own specifics and route the completed report 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.
Document control header
| Field | Entry |
|---|---|
| Document title | CDMO Technical Assessment Summary Report for <<FILL: program / product>> at <<FILL: CDMO name>> |
| Document number | <<FILL: e.g. DD-2026-04-SUM>> |
| Version | <<FILL>> |
| Report date | <<FILL>> |
| CDMO and site(s) assessed | <<FILL>> |
| Linked due diligence plan | <<FILL: document number>> |
| Linked scorecard | <<FILL: document number>> |
| Linked disposition register | <<FILL: document number>> |
| Report author | <<FILL>> |
1. Purpose
This report summarizes the technical assessment of <<FILL: CDMO name>> for <<FILL: program / product>>, states the recommendation in plain language, and explains the reasoning behind any non-obvious call, so the decision record stands on its own without requiring a reader to reconstruct the story from the underlying scorecard and register.
2. Scope
| Dimension | Decision |
|---|---|
| Process / service assessed | <<FILL>> |
| Site(s) covered by this report | <<FILL>> |
| Assessment period | <<FILL: start and end date of the due diligence activity>> |
| Out of scope | <<FILL: e.g. commercial and pricing terms, covered under a separate business review>> |
3. Responsibilities
| Role | Responsibility |
|---|---|
| Report author (lead assessor) | Drafts this report from the completed scorecard and disposition register |
| Technical operations / MSAT, Analytical / QC, Quality Assurance, Regulatory / CMC | Review the report for accuracy against their own scored sections before it is issued |
| Executive sponsor | Reads this report as the primary decision document and records the final selection decision |
4. Summary of assessment activity
State plainly what was actually done, not what the plan intended to do; a deviation from the plan belongs here, not silently absorbed into the narrative.
| Activity | Completed | Date(s) | Notes |
|---|---|---|---|
| Information package reviewed | <<FILL: Yes/No>> | <<FILL>> | <<FILL>> |
| Scorecard completed | <<FILL>> | <<FILL>> | <<FILL>> |
| Site visit or virtual assessment conducted | <<FILL>> | <<FILL>> | <<FILL: in-person/virtual, who attended>> |
| Independent reference call(s) completed | <<FILL>> | <<FILL>> | <<FILL: arranged independently of the CDMO, confirm>> |
| Independent regulatory standing check completed | <<FILL>> | <<FILL>> | <<FILL: FDA Inspection Classification Database / EudraGMDP>> |
5. Results against the decision rule
| Field | Entry |
|---|---|
| Weighted scorecard total | <<FILL>> |
| Decision rule threshold (from the scorecard) | <<FILL>> |
| Red flags identified | <<FILL: count>> |
| Red flags with a documented QA risk acceptance | <<FILL: count, should equal the total above before this report is issued>> |
| Any single dimension scored 0 or 1 on a scope-critical criterion | <<FILL: Yes/No, which dimension>> |
6. Key findings that drove the recommendation
List only the findings that materially shaped the recommendation, typically two to five; the full finding list lives in the disposition register and does not need to be repeated here.
| Finding | Why it mattered to the recommendation | Disposition |
|---|---|---|
<<FILL>> | <<FILL>> | <<FILL: reference the register's Finding ID>> |
<<FILL>> | <<FILL>> | <<FILL>> |
7. Deviations from the due diligence plan
| Planned activity not completed, or completed differently than planned | Reason | Impact on confidence in the recommendation |
|---|---|---|
<<FILL: e.g. a reference call could not be arranged independently>> | <<FILL>> | <<FILL: state plainly whether this weakens the recommendation>> |
Leave this section stated as “none” rather than omitted if the assessment ran exactly to plan; a reader checking this report against the due diligence plan is checking for exactly this kind of silent gap.
8. Conclusion and recommendation
State the recommendation in the first sentence of this section, Recommend, Recommend with conditions, or Do not recommend, then the reasoning in two or three sentences a reader outside the assessment team can follow without opening the scorecard or the register.
<<FILL: recommendation and reasoning>>
9. Next steps and conditions
| Condition or next step | Owner | Target date |
|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> |
10. References
FDA guidance, “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (November 2016). ICH Q9(R1), Quality Risk Management. ICH Q10, Pharmaceutical Quality System.
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 |
|---|---|---|---|
| Report author (lead assessor) | <<FILL>> | ||
| Quality Assurance | <<FILL>> | ||
| Executive sponsor | <<FILL>> |
Filled specimen
Extract from the summary report closing out the assessment of a fill-finish CDMO for Acme Therapeutics’ ATX-410 lyophilized biologic. Company, product, and numbers are illustrative, and this specimen follows the same assessment referenced in the paired scorecard and disposition register.
| Field | Entry |
|---|---|
| Assessment period | Document request through decision summary, six weeks, documented in the linked due diligence plan |
| Weighted scorecard total | 3.35 of 4, against a decision rule threshold of 3.0 for Recommend |
| Red flags identified | One, audit trail review inconsistency, risk-accepted by QA conditional on a written corrective action plan |
| Key finding 1 | CDMO’s lyophilizer chamber is roughly three times the scale ATX-410 was characterized on; closed by a bridging engineering run before PPQ protocol approval, see register F-003 |
| Key finding 2 | Audit trail review had no defined frequency by data criticality; required a written corrective action plan before the first GMP batch |
| Key finding 3 | Potency reference standard sourced from a single, non-redundant vendor; accepted as is, Acme already holds a qualified backup lot, see register F-005 |
| Deviations from plan | None; all planned activities, including one reference call arranged independently of the CDMO, were completed |
Conclusion and recommendation, as written in the actual report: “Recommend with conditions. The site’s deviation and tech transfer track record, four prior transfers meeting PPQ timeline within 5 percent, and its proactive disclosure of its own audit trail gap during the assessment, support proceeding. Two conditions apply before the first GMP batch: a bridging engineering run confirming shelf temperature uniformity at full lyophilizer load, and a written, QA-approved audit trail review frequency by data criticality. Neither condition is expected to affect the target signature date.”
The specimen shows what this report is for: a reader who has never seen the scorecard or the register can finish these few paragraphs and know exactly what was decided, why, and what still has to happen before the first batch.
Common inspection findings this report prevents
- A selection decision recorded only as a verbal recommendation in a meeting, with no document an inspector or a new team member can read to understand why the CDMO was chosen.
- A report that restates every row of the scorecard and register in prose, so long that the executive sponsor skims it rather than reading it, defeating the purpose a summary report exists to serve.
- A recommendation stated without the reasoning behind a non-obvious call, so a later reviewer cannot tell whether a condition was a real risk management decision or an oversight.
- A deviation from the due diligence plan, a reference call that could not be arranged independently, for example, absorbed silently into the narrative instead of disclosed and assessed for its impact on confidence in the recommendation.
How to adapt this report
- Set your document number and the linked due diligence plan, scorecard, and register references in the header.
- Keep section 6 to the findings that actually drove the recommendation; point to the register for everything else rather than duplicating it.
- Write the conclusion in section 8 so it stands alone; a reader should not need to open any other document to understand the recommendation and why.
- Complete section 7 honestly even when the answer is “none”; an omitted section reads as an oversight, not as a clean record.
- Confirm every reference in section 10 against the current published version before issue.