What is QP on Demand? A Qualified Person (QP) as defined in Article 49 of EU Directive 2001/83/EC is responsible for the batch release of medicinal products. “QP on Demand” means: ENTOURAGE provides experienced, officially recognized Qualified Persons on short notice and with flexibility—for vacation cover, vacancies, capacity bottlenecks, or as a permanent external QP solution.
Use cases: When the need becomes acute.
Pharmaceutical companies, CDMOs and importers are familiar with the scenario: when workloads are high or there are sudden staff changes, the pressure on the internal organization increases. Batch releases in accordance with AMG, GMP guidelines and other regulatory requirements must still be carried out promptly in order to avoid delays and loss of sales. CDMOs in particular often reach their capacity limits when several customer projects have to be handled in parallel.
Our "QP on Demand" service is designed specifically for these situations. We provide QP expertise on short notice to ensure your compliance and enable the seamless continuation of your business operations.
Do you need a qualified person on short notice?
We handle temporary batch release for your company—in full compliance with legal requirements and GMP standards. Learn more about our comprehensive services on our official service page.
About our QP on Demand ServiceWhat sets our "QP on Demand" service apart?
- Immediate availability: We can provide you with experienced QPs within a few days.
- Maximum flexibility: Tailored support for exactly as long as you need it—whether for a specific project or on an interim basis.
- Technical Expertise: Our Qualified Persons meet all regulatory requirements under Section 15 of the German Medicines Act (AMG), Annex 16 of the EU GMP Guidelines, and the Clinical Trials Regulation (EU) No. 536/2014.
- Cost-effectiveness: You avoid long-term commitments or additional personnel costs.
How does "QP on Demand" work at ENTOURAGE?
- 01 — Needs Assessment: Define the product portfolio, dosage forms, manufacturing sites, and scope of approval.
- 02 — QP Matching: Assign a suitable QP with relevant expertise and product experience from the ENTOURAGE pool.
- 03 — Onboarding: Integrate the Qualified Person into existing processes: QMS, batch records, deviation handling.
- 04 — Release: Ongoing batch release and GMP review. Documentation and assumption of responsibility.
- 05 — Transition: If necessary: Handover to internal QP, including knowledge transfer and onboarding support.
When can you benefit most from "QP on Demand"?
- If batch releases are required at short notice.
- For staff shortages or interim solutions.
- To ensure audit and inspection readiness.
- For specific regulatory challenges and projects.
Recommendations for optimal cooperation.
- Communicate your requirements at an early stage.
- Clarify the precise scope of the support required in advance.
- Plan regular coordination to ensure smooth integration into your processes.
"QP on Demand" from ENTOURAGE offers pharmaceutical companies, CDMOs, and importers exactly the flexibility and reliability that are crucial at critical moments. It ensures compliance, prevents production downtime, and provides access to expertise that minimizes regulatory risks.