This is a ready-to-use scorecard for the technical assessment of a contract development and manufacturing organization (CDMO), typically completed during or after an on-site or remote audit. Replace every <<FILL: ...>> placeholder with your own specifics and route the completed scorecard 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 Scorecard for <<FILL: CDMO name>> |
| Document number | <<FILL: e.g. CDMO-TA-2026-07>> |
| Version | <<FILL>> |
| Assessment date(s) | <<FILL>> |
| CDMO assessed | <<FILL: name, site address>> |
| Scope of proposed work | <<FILL: product, process, service, e.g. drug product fill-finish>> |
| Assessor(s) | <<FILL: name(s), role(s)>> |
1. Purpose
This scorecard structures the technical assessment of <<FILL: CDMO name>> for the proposed scope of work, so the selection decision rests on scored, evidenced criteria rather than impression, and so the same criteria are applied consistently across every CDMO under consideration.
2. Scope
| Dimension | Decision |
|---|---|
| Site(s) assessed | <<FILL>> |
| Process / service scope | <<FILL: e.g. drug substance, drug product, packaging, testing>> |
| Assessment type | <<FILL: initial selection / periodic reassessment>> |
| Out of scope | <<FILL: e.g. commercial terms, covered under a separate business review>> |
3. Responsibilities
| Role | Responsibility |
|---|---|
| Lead assessor | Facilitates the assessment, compiles scores, and drafts the decision summary. |
| Technical / manufacturing SME | Scores capability, capacity, and transfer track record with evidence. |
| Quality Assurance | Scores quality systems and data systems, and confirms any red flag is fully investigated before scoring proceeds. |
| Regulatory / CMC | Confirms the site’s inspection history and regulatory standing feed the assessment. |
4. Scoring rubric
Score each dimension 0 to 4 against the evidence actually seen, not the CDMO’s own claims. A score of 3 or 4 requires objective evidence (a record, a document, a demonstrated system); a claim with no evidence scores no higher than 2.
| Score | Meaning |
|---|---|
| 4 | Strong, evidenced, matches or exceeds what the scope requires |
| 3 | Adequate, evidenced, minor gaps that do not threaten the scope |
| 2 | Partial or unevidenced; claimed but not demonstrated |
| 1 | Significant gap relative to what the scope requires |
| 0 | Absent, or a known failure in this area |
5. Scored sections
| Dimension | What it covers | Weight | Score (0-4) | Evidence / notes |
|---|---|---|---|---|
| Capability | Relevant process/technology experience for this modality and scope | <<FILL: e.g. 20%>> | <<FILL>> | <<FILL>> |
| Capacity | Available suite time, equipment train, staffing against the proposed timeline | <<FILL>> | <<FILL>> | <<FILL>> |
| Quality systems | Deviation/CAPA maturity, change control, recent inspection history and citations | <<FILL>> | <<FILL>> | <<FILL>> |
| Data systems | MES/LIMS/historian validation state, audit trail review practice, data integrity governance | <<FILL>> | <<FILL>> | <<FILL>> |
| Analytical | In-house test capability, method transfer/validation experience, outsourced test lab oversight | <<FILL>> | <<FILL>> | <<FILL>> |
| Tech transfer track record | Number and outcome of prior transfers of similar complexity, on-time PPQ record | <<FILL>> | <<FILL>> | <<FILL>> |
| Culture / communication | Responsiveness, transparency about problems, escalation behavior during the assessment itself | <<FILL>> | <<FILL>> | <<FILL>> |
Weights should sum to 100 percent and should be set before the assessment, not adjusted afterward to fit a preferred outcome.
6. Red-flag list
Mark any that apply. A red flag does not automatically disqualify the CDMO, but each one requires a documented risk acceptance from Quality Assurance before the decision proceeds, regardless of the weighted score.
- Open FDA Form 483 observations or a warning letter touching the proposed scope, unresolved.
- No audit trail review practice for GxP-relevant computerized systems.
- Repeated missed milestones on prior transfers with no documented root cause.
- Quality unit with no independent authority over production (reports through operations).
- Unwillingness to allow direct access to deviation, CAPA, or audit trail records during the assessment.
- Data integrity finding in the last
<<FILL: e.g. 3 years>>with no verified, closed CAPA.
| Red flag identified | Description | QA risk acceptance |
|---|---|---|
<<FILL: Yes/No>> | <<FILL>> | <<FILL: name, date, or N/A>> |
7. Decision summary
Set the threshold below before scoring begins and document it as the decision rule, not a rationalization applied after the fact. A reasonable starting default, tune to your own risk tolerance and modality: a weighted total at or above 3.0 with no unresolved red flag supports Recommend; 2.0 to 2.9, or any red flag risk-accepted by QA with a documented condition, supports Recommend with conditions; below 2.0, or an unresolved red flag with no QA risk acceptance, supports Do not recommend. Override the arithmetic when it hides a single disqualifying gap: a score of 0 or 1 on a dimension central to the scope, Capability for a novel modality, Quality systems for a sterile product, should drive Do not recommend regardless of the weighted total, because a strong average can mask one gap that alone makes the site unusable for this program.
| Field | Entry |
|---|---|
| Weighted total score | <<FILL: sum of weight x score across section 5>> |
| Red flags present | <<FILL: Yes/No; count>> |
| All red flags risk-accepted by QA | <<FILL: Yes/No/N/A>> |
| Any single dimension scored 0 or 1 on a scope-critical criterion | <<FILL: Yes/No; which dimension>> |
| Recommendation | <<FILL: Recommend / Recommend with conditions / Do not recommend>> |
| Conditions, if any | <<FILL>> |
| Decision and decision-maker | <<FILL>> |
8. References
ICH Q10, Pharmaceutical Quality System, outsourced activities. FDA guidance, “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (November 2016). 21 CFR Part 211, current good manufacturing practice for finished pharmaceuticals.
Confirm the current version of each reference before issue.
9. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
10. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Lead assessor | <<FILL>> | ||
| Quality Assurance | <<FILL>> | ||
| Approver (Outsourcing / CMC leadership) | <<FILL>> |
Filled specimen
Extract from an example assessment of a fill-finish CDMO for a lyophilized biologic. Company and CDMO names are illustrative.
| Dimension | Weight | Score | Evidence / notes |
|---|---|---|---|
| Capability | 20% | 3 | Six lyophilized biologics in commercial production; no prior experience with this specific formulation class |
| Capacity | 15% | 3 | Suite available within Acme’s timeline; one train, no redundancy if it goes down |
| Quality systems | 20% | 4 | Deviation and CAPA records reviewed directly; last FDA inspection VAI, CAPAs closed and verified |
| Data systems | 15% | 2 | LIMS validated; audit trail review practice inconsistent across shifts, no defined frequency by data criticality |
| Analytical | 10% | 3 | In-house release testing capable; CCIT method transfer experience limited to one prior client |
| Tech transfer track record | 15% | 4 | Four prior transfers of similar complexity, all met PPQ timeline within 5 percent |
| Culture / communication | 5% | 4 | Proactively disclosed the audit trail review gap before it was asked about |
Weighted total: 3.35 of 4. Red flag: audit trail review inconsistency noted but not on the automatic list; QA risk-accepted it conditional on a written corrective action plan and a documented review frequency in place before batch release testing begins under this agreement. Recommendation: recommend with conditions.
The specimen shows the pattern that matters: a real gap (data systems) scored honestly rather than smoothed over, disclosed proactively by the CDMO itself, and converted into a documented condition rather than either an automatic pass or an automatic disqualification.
Common inspection findings this scorecard prevents
- A CDMO selected on relationship or price with no documented technical assessment on file.
- Scores assigned from the CDMO’s own claims with no evidence reviewed directly.
- A known red flag (an open 483, a data integrity finding) never risk-assessed or accepted by QA.
- Weights adjusted after the fact to justify a decision already made.
- A quality agreement executed before the technical gaps identified in the assessment are addressed or accepted.
How to adapt this scorecard
- Set your document number, CDMO, and scope of proposed work in the header.
- Set section weights in section 5 to reflect what actually matters for your modality and risk profile before you score, not after.
- Extend the red-flag list in section 6 with any disqualifiers specific to your product class (for example, cold-chain failure history for a biologic).
- Require objective evidence, not a claim, for any score of 3 or 4.
- Route every red flag through a documented QA risk acceptance before the decision summary is finalized.
- Confirm every reference in section 8 against the current published version before issue.