Seamless QP Coverage After a Short-Notice Absence
Pharmaceutical company with an internal Qualified Person
The short-notice absence of the internal Qualified Person threatened supply-chain continuity and regulatory compliance.
The challenge
The situation
The short-notice absence of the internal Qualified Person threatened to jeopardise supply-chain continuity and carried the risk of regulatory non-compliance and possible supply interruptions. A fast solution for QP coverage was needed, in line with the existing quality systems.
Our approach
What we delivered
Temporary substitution of the Qualified Person
Integration of a QP-on-demand model
Alignment with the company-wide quality systems
The outcome
Results & impact
33% cost reduction
Lower cost of QP coverage compared to the starting situation.
6 months to audit readiness
Audit readiness achieved within six months.
No supply interruptions
Continuous QP coverage without interruption of the supply chain.
In summary
QP coverage was maintained seamlessly despite the short-notice absence, in line with the existing quality systems and at markedly lower cost.
Related expertise
QP on Demand →
Describes exactly the flexible QP-on-demand model that Entourage implemented in this case study to safeguard batch release at short notice.
Good Manufacturing Practice (GMP) →
The Qualified Person's duties are a core part of the GMP quality system, to which the temporary QP solution was closely tied.
Qualitätsmanagement →
The case study required aligning the temporary QP with the client's existing company-wide quality management processes.
Lieferengpässe managen →
The QP absence threatened to trigger an immediate supply interruption, averted by Entourage's rapid solution.
Similar projects
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Sources
- Entourage project experience (anonymised)
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