This is a ready-to-use work instruction for conducting a CDMO reference call as part of the technical assessment. It is a task-level companion to the CDMO Technical Due Diligence Plan: that plan scopes the whole assessment, this instruction governs the single task of running one reference call well. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
Purpose and parent document
This work instruction supports Step <<FILL: reference to the due diligence plan's step number>> of the CDMO Technical Due Diligence Plan. It exists because a reference call arranged entirely by the CDMO tends to produce only the story the CDMO chose to tell; this instruction is written for a reference contact reached independently, through a professional network, a prior colleague, or a public case study, not one supplied by the CDMO’s sales team.
Before the call
- Confirm the reference was reached independently of the CDMO’s introduction. If the CDMO supplied every reference contact on the list, note this as a red flag per the technical assessment’s red flag table and continue seeking an independent contact rather than treating the CDMO-supplied list as sufficient.
- Confirm the reference’s program at this CDMO is comparable in modality, scale, or complexity to the program under assessment; a reference for a small-molecule oral solid program says little about a first-in-class cell therapy campaign at the same site.
- Send the reference a short list of topics in advance, not the full question set, so the call stays conversational rather than an interrogation read off a script.
During the call: structured question set
| # | Question | What a strong answer sounds like | What a weak or evasive answer sounds like |
|---|---|---|---|
| 1 | Tell me about a time something went wrong on your program. How did the site handle it? | A specific, named event with a clear account of how it was escalated, investigated, and resolved | A vague assurance that “everything went smoothly,” with no specific event offered |
| 2 | How quickly does the site escalate a deviation or a schedule risk to you, versus waiting for you to ask? | Proactive escalation, named examples of the site raising bad news first | Reactive: problems surface only when the sponsor asks directly |
| 3 | Has the site ever pushed back on an unrealistic request from your team? What happened? | A specific example where technical or quality staff, not just business development, said no or flagged a real constraint | No example, or an answer suggesting the site agrees to everything asked |
| 4 | How has your key technical contact’s tenure and continuity been over the program? | Stable technical contacts across the program’s life, or a documented, well-managed handoff | Frequent turnover with no visible knowledge-transfer process |
| 5 | If you were starting this program again, would you choose this site? Why or why not? | A specific, reasoned answer, including named tradeoffs, either way | A generic “yes, they’re great” with nothing behind it |
| 6 | How did the site perform against its committed timeline, and how did it communicate a slip if one happened? | A specific account of an actual timeline, hit or missed, and how communication worked either way | No specifics, or defensiveness about the question |
| 7 | What would you tell a colleague to watch out for at this site? | A specific caution the sponsor can actually use, even a minor one | ”Nothing really,” offered without hesitation on a multi-year manufacturing relationship |
After the call
- Record the reference’s answers against the disposition register alongside the rest of the technical assessment’s findings, not in a separate, informal note that never reaches the record.
- Where the reference surfaces a specific concern, route it to Quality Assurance or the executive sponsor for a documented risk acceptance or further diligence, per the technical assessment’s normal disposition process; do not let a reference-call finding disappear because it arrived informally.
- Weigh a reference call’s culture-related findings, question 2 and question 3 above especially, as seriously as a capability finding; culture is the hardest of the three assessment dimensions to observe directly and a candid reference call is one of the few ways to get at it before signing.
Filled specimen
Extract from Acme Therapeutics’ reference call for Meridian Fill Services, reached independently through a technical operations contact at a prior employer, not supplied by Meridian’s sales team.
| Question | Reference’s answer |
|---|---|
| Something going wrong | Described a 2025 stopper-seal deviation on their own program; Meridian’s floor quality lead escalated within the shift, root cause traced to a torque setting drift, corrective action verified across the next three batches |
| Proactive escalation | Confirmed Meridian’s technical contact flagged a raw-material lead-time risk six weeks before it would have affected the schedule, without being asked |
| Pushback on an unrealistic request | Meridian’s process engineer declined a request to compress an engineering run timeline, citing insufficient time to bracket shelf temperature at full load; the reference’s own team agreed in hindsight the pushback was correct |
| Would choose again | Yes, specifically citing consistent technical contact continuity across a three-year program |
Disposition: no red flag raised; culture assessment scored favorably, corroborating the technical assessment’s other findings rather than contradicting them.
Common findings this instruction prevents
- Every reference contact supplied by the CDMO, producing a uniformly positive picture that never gets independently tested.
- A reference call that happens but is never recorded against the assessment’s actual findings record.
- A culture-relevant concern raised informally on a reference call that never reaches Quality Assurance for a documented disposition.
- A reference call run against a program that is not actually comparable to the one under assessment, producing false reassurance.
How to adapt this instruction
- Adjust the question set to the specific modality and risk profile of your program.
- Confirm your own technical assessment’s disposition register is the actual destination for reference-call findings, not a side note.
- Set your own standard for how many independently-reached references are required before the assessment is considered complete.