Key-person risk in CDMOs

A CDMO sells reliability to its clients. When one project manager holds the client relationship, or one scientist holds the transfer know-how, the client feels every absence.

Where does dependency concentrate in a CDMO?

• Technology transfer. Steps are done from experience instead of an approved procedure or template.
• Client documentation. The final batch documentation package waits for one person to assemble it.
• Client updates. Status goes out by email, call and meeting, and only the project manager knows the latest state.
• Batch records and deviations. Corrections after QA review and investigations that queue behind specialists, as at any manufacturer.

Which KPIs does the screening use for CDMOs?

• Client documentation turnaround: days from approval of the last QC result to delivery of the final batch documentation package to the client.
• Tech transfer without procedure: share of technology transfer steps done without an approved step-by-step procedure or template.
• Batch records returned: share of executed batch records sent back for at least one correction at first QA review.
• Deviation closure time: average calendar days from opening a deviation to QA approval of the closed investigation.
• Manual client updates: share of routine client status updates sent by email, call or meeting instead of a portal or automated feed.

If you do not have a figure, the screening uses the industry median.

What does the audit look at in a CDMO?

The workshop follows one client project from transfer to delivery and asks what happens when its key people are away. The result shows which projects depend on individuals and which processes to standardise first, so that capacity can grow without hiring more irreplaceable people.

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