Uninterrupted 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 jeopardize supply-chain continuity and carried the risk of regulatory non-compliance and possible supply interruptions.
Our approach
What we delivered
Temporary substitution of the Qualified Person, so that the sudden absence does not turn into a supply interruption.
Integration of a QP-on-demand model that secures coverage permanently instead of leaving it dependent on a single person.
Alignment with the existing quality systems, because otherwise an external solution creates precisely the regulatory risk it is meant to avert.
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 without interruption despite the short-notice absence, in line with the existing quality systems and at markedly lower cost.
Related expertise
QP on Demand →
Batch release under Art. 51 of Directive 2001/83/EC and interim QP cover for vacancies
GMP Consulting (Good Manufacturing Practice) →
Building the quality system with SOPs, batch records and change control
Quality Management →
Setting up the QMS to the EU GMP Guide, with CAPA and complaint handling
Managing Supply Shortages →
Contingency planning and a crisis process for imminent supply interruptions
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Sources
- Entourage project experience (anonymized)
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