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What Does a Responsible Person Really Do? And How does it compare to GMP (What is GMP?)

Автор: Help Me GMP | GMP GDP Pharma Training | HelpMeGMP

Загружено: 2025-09-08

Просмотров: 73

Описание:

Clear, no-fluff training on the Responsible Person (RP) role for Wholesale Distribution Authorisations — human [WDA(H)] and veterinary [WDA(V)]. In this Help Me GMP video, Charlie explains what an RP does, how GDP protects medicines after batch release, and how the RP compares with manufacturing roles (Head of Production, Head of QC, and the Qualified Person). Perfect for distributors, 3PLs, wholesalers, and QA/Operations teams preparing for MHRA GDP inspection.

What you’ll learn:
• What the RP is and why every WDA needs one
• Core RP duties: QMS oversight, supplier/customer approval, temperature control, traceability, investigations, complaints/returns/recalls, and controlled delegation
• How GDP differs from GMP — and how the RP’s remit differs from Head of Production, Head of QC, and the QP
• The background, training, and CPD expected of an RP
• Common GDP pitfalls that put your WDA at risk — and how to avoid them
• Why the RP role matters more than ever (cold chain, globalised supply, counterfeit risks, data integrity)

Key takeaways:
• GMP protects how medicines are made; GDP protects how they move
• The RP is legally accountable for GDP compliance and supply-chain integrity
• Real authority, visibility, and active involvement are essential for inspection readiness

Who is this for?
• Current and aspiring RPs
• GDP leads, warehouse managers, and 3PL partners
• QP, Head of Production, Head of QC seeking role clarity across GMP vs GDP
• Any organisation operating under WDA(H) or WDA(V)

About Help Me GMP
We provide free, plain-English training for GMP, GDP, and compliance professionals. Subscribe for more practical guides, walkthroughs, and role explainers.

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What Does a Responsible Person Really Do? And How does it compare to GMP (What is GMP?)

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