Virtual business Model (Procure and Supply) - Supply Chain Considerations/EU Product Distribution

• What Authorizations are needed based on your Global Supply Chain?

• What contract storage sites need to be detailed on your Wholesale Dealer’s Authorisation?

• WDA variations for virtual companies – typically pitfalls?

• Adding a Contract RP – HPRA expectations?

• Flash Sale/Direct to pharmacy – which is best for the RP/business?

• HPRA Hot Topics for virtual WDA holders?

• HPRA Inspection Trends/Common Deficiencies for virtual WDA holders?

• GDP Case studies/scenarios for virtual WDA holders 

• CMO/Virtual companies – HPRA oversight requirements

• Management Review – Proactive Quarterly approach

• Supplier/Customer Management

• RP responsibilities and requirements for virtual companies

HPRA Inspection Remediation - Contract RP Role

• Following a HPRA inspection, significant GDP compliance deficiencies were identified at a Dublin-based wholesaler. 

• The site lacked an appointed Responsible Person (RP) for over six months, with key RP duties, approving QMS updates, supplier qualification, and product returns performed by unqualified staff. 

• Major findings included i) use of unvalidated cold-chain transport systems, ii) incomplete deviation management, iii) inadequate supplier bona fides, and iv) poor oversight of outsourced transport providers. 

• This contract RP assignment focuses on restoring GDP compliance through CAPA implementation, validation of temperature-controlled systems, reinstatement of RP governance, procedural revision, and requalification of suppliers, ensuring full regulatory alignment and patient safety.

• Are you up to this task as the newly onboarded contract RP?? 

EU GDP - A Practical Guide

This 2 day online training course at NIBRT is specifically designed as a practical guide for new warehouse/GDP personnel looking for training in GDP operations. 

The course covers the following GDP chapters, Premises & Equipment, Operations and Transport.

• Day 1 is focussed on Warehouse activities (Product Storage/Facility Layout and Equipment Qualification)

• Day 2 is focussed on GDP Transport solutions (Shipping validation and Global supply chains) and transport solution 

• Optional half day 3 includes a "live" GDP Facility Site Tour

Learn more about the course and book your spot at NIBRT at the link below.

https://www.nibrt.ie/product/good-distribution-practice-a-practical-perspective/#register-for-corse