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 October 11, 2023

Updated on October 11, 2023

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

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