Qualified person (QP) and Batch release related – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

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Updated on April 2, 2026

Updated on April 2, 2026

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
EU GMP guide annexes: Supplementary requirements: Annex 16 (Guidance on good manufacturing practice and good distribution practice: Questions and answers)
Europe CMDh – Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) – Questions & Answers – QP Declaration

Tags : EMA

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