Qualified person (QP) and Batch release related

EU GMP Annexure 16 Guidance’s, Qualified Person (QP), Batch Release, QP Declaration, Templates

• EU GMP Annexure 16: Certification by a Qualified Person and Batch Release (EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines Annexes)
• EU GMP Annexure 16 Guidance for QP Declaration Template: Guidance for the template for the qualified person’s declaration concerning GMP compliance of active substance manufacture “The QP declaration template”
• EU GMP 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