Key-person risk in pharmaceutical manufacturing

Established pharma plants have mature procedures, and that can hide dependency: the procedure exists, but only one person knows how to make it work when something unusual happens.

Where does dependency concentrate in a pharma plant?

• Release. QP certification waits for one person after the last QC result.
• Change control. Impact assessments queue behind the few people who understand the process.
• Stability. Reports are assembled by hand from several systems.
• Paper evidence. GMP-critical steps are evidenced only by a paper sign-off.
• Regulatory submissions. The final dossier waits for one regulatory specialist.

Which KPIs does the screening use for pharma?

• Regulatory submission lag: days from final approval of the last dossier document to confirmed receipt by the agency.
• Change control approval time: days from change initiation to QA approval of the impact assessment and implementation plan.
• Stability report assembly: hours of manual work per stability report.
• Paper-only SOP steps: share of GMP-critical SOP steps evidenced only by a paper sign-off, or not recorded, instead of captured by a validated system.
• QP release lag: days from approval of the last QC release result to QP certification.

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

What does the audit look at in a pharma plant?

The workshop takes the processes you select, such as release, change control or stability, and asks what happens when the person who usually does the work is away. Required reviews do not raise the score; extra checks on top of them and waiting for one specific reviewer do.

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