This is a ready-to-use, living map of which process step runs at which site across a CDMO network, and which of the sponsor’s own programs or products share a site or a specific piece of equipment. Replace every <<FILL: ...>> placeholder. Update it whenever a process step, a site, or a program changes, and treat “last verified” as its own field to check at every joint quality review, not a one-time build. A filled specimen follows.
Instructions
This map is narrower and more current than a supply chain diagram. A supply chain diagram shows which vendor performs which function; this map shows exactly which equipment train and which process step, so an impact assessment during a live deviation, or a change control review before implementation, can check a shared exposure in minutes rather than reconstruct it from memory. Assign standing ownership of keeping it current to the same role that owns the escalation ladder and the deviation notification log.
Field definitions
| Field | Format | Required | Who completes it | When |
|---|---|---|---|---|
| Process step | <<FILL: e.g. viral vector purification, TFF concentration, fill-finish>> | Yes | Supply chain quality | At map creation, updated as steps change |
| Site(s) performing this step | Named site(s) | Yes | Supply chain quality | At map creation |
| Specific equipment train, if shared exposure matters | <<FILL: e.g. bioreactor skid model + serial, lyophilizer unit>> | Yes, where relevant | Supply chain quality, from site records | At map creation |
| Sponsor programs/products sharing this site or equipment | <<FILL>> | Yes | Supply chain quality | At map creation, updated when a program is added |
| Upstream dependency | <<FILL: the step this one depends on>> | Yes | Supply chain quality | At map creation |
| Downstream dependency | <<FILL: the step this one feeds>> | Yes | Supply chain quality | At map creation |
| Last verified date | Date | Yes | Supply chain quality | Every joint quality review at minimum |
Map
| Process step | Site(s) | Equipment train | Sponsor programs sharing this exposure | Upstream | Downstream | Last verified |
|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Use at impact assessment and change control
| Question the map answers | Where it is used |
|---|---|
| Does another program in our own network run this exact step, at this site or a different one? | Impact assessment, cross-network check |
| Does this site’s equipment train serve any other sponsor’s product? | Impact assessment, shared-capacity risk |
| Was a downstream site’s process validated using output from the step that is now changing? | Change control, bridging study scoping |
| When was this entry last confirmed against the site’s actual current operation? | Every joint quality review |
Filled specimen
Acme Therapeutics built this map for its two advanced-therapy programs, ATX-330 (AAV gene therapy) and ATX-410 (a cell therapy program added eighteen months later), after discovering during a live deviation that both programs’ drug product used the same lyophilizer at CMO Gamma.
| Process step | Site(s) | Equipment train | Sponsor programs sharing this exposure | Upstream | Downstream | Last verified |
|---|---|---|---|---|---|---|
| Viral vector purification (AAV) | CMO Alpha | Chromatography skid AC-2, serial <<FILL>> | ATX-330 only | Upstream bioreactor harvest | TFF concentration | 2026-08-15 |
| TFF concentration and formulation | CMO Alpha | TFF skid TF-1 | ATX-330 only | Viral vector purification | Fill-finish, CMO Gamma | 2026-08-15 |
| Lyophilization | CMO Gamma | Lyophilizer LY-3 | ATX-330 and ATX-410 | Fill (respective sites) | Packaging | 2026-09-01 |
| Cell processing and expansion | CMO Beta | Bioreactor skid BR-4, same model as CMO Alpha’s harvest skid but different serial | ATX-410 only | Apheresis intake | Formulation, CMO Beta | 2026-09-01 |
The shared lyophilizer row is what the map exists to catch. When a lyophilization cycle deviation occurred on LY-3 during an ATX-410 batch, the impact assessment used this map to confirm within minutes that ATX-330’s next scheduled lyophilization run on the same unit needed to be held pending the deviation’s root cause, a check that would otherwise have required calling CMO Gamma directly and waiting for a response while the second batch’s timeline continued to run.
Common inspection findings this map prevents
- A shared-equipment or shared-material exposure discovered by accident during an investigation, because no record of the overlap existed before the event.
- A map built once during onboarding and never updated, so a program added or retired since is missing or stale, and “last verified” is nobody’s stated responsibility.
- An impact assessment that took days to answer “does this affect anything else” because the cross-check had to be reconstructed from site visit notes and email threads instead of read off a current record.