QP Delegate
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The QP Delegate serves as a key quality assurance representative, supporting the Qualified Person (QP) in ensuring compliance with regulatory requirements and internal quality standards for the release of commercial and clinical batches. While the QP delegate has the responsibility for approving the batch release dossier based on a detailed review of the batch release dossier content, the QP delegate relies on the pharmaceutical quality system of the site under the responsibility of the Qualified Person.
Key Responsibilities
- Quality & Batch Release
- QP Governance & Escalation
- Deviations & Change Control
- Analytical & Product Specifications
- Product Review
- Shipment & Export
- Reference Samples