Qualified person (QP) and Batch release related – Qvents

Qvents

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Warning letters, 483s, Recalls, Import Alerts, Audit observations

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Updated on January 30, 2025

Updated on January 30, 2025

Annex 16: Certification by a Qualified Person and Batch Release (EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines Annexes)
Guidance for the template for the qualified person’s declaration concerning GMP compliance of active substance manufacture “The QP declaration template”
Template for the qualified person’s (QP) declaration concerning good manufacturing practice compliance of active substance manufacture “The QP declaration template” – Scientific guideline & Template
Europe CMDh – Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) – Questions & Answers – QP Declaration

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