Responsible Person Forum

Our Responsible Person Forum, provides an opportunity for networking, sharing best practice and discussing current issues with practicing RPs and colleagues working in the GDP field. Each month has a defined topic, as follows :

• January 2024 – GDP Inspection Reports Review - Learning from the mistakes of others.
  Further details

  • In 2022 a large UK wholesaler collapsed into administration, partly caused by the MHRA suspension of their wholesale dealers' licence. Using a Freedom of Information request MHRA provided a copy of the inspection letter that led up to the suspension of their WDA in 2021. We will examine and discuss where the critical failures occurred and what should be in place in your organisation to prevent similar issues arising. Topic areas covered in the webinar include:
  • Demonstrating the effectiveness of the QMS
  • Effective deviation investigations, CAPAS, change control and management review
  • Defining the roles, accountabilities and responsibilities of the Responsible Persons
  • Qualification of customers
  • Review of suspicious transactions
  • Accuracy of records
  • An overview of the MHRA Inspection Action Group process
  
  

  
  
• March 2024 – Master data and Control of Supply, its role in GDP
  Further details

  • Accurate master data is critical for wholesale distributors as it provides the single source of truth for their enterprise resource planning (ERP) systems, including customer types, product specifications and inventory data. We will discuss some examples where inaccurate master data has caused regulatory issues for companies and provide a forum to discuss best practices in this area. Topic areas covered in the webinar include:
  • Data integrity principles (ALCOA) Attributable, Legible, Contemporaneous, Original, and Accurate
  • Understanding ownership of master data and where Responsible Person input and oversight is required
  • How to demonstrate the regulatory compliance of your data
  
  

  
  

• May 2024 – Management of Outsourced Activities – Best Practice and Compliance Risks
• July 2024 – Qualification and Validation of equipment and processes
• September 2024 – Preparation for the Windsor Protocol
• November 2024 - QualityCulture, its impact on GDP and benefits for the RP
  
  

The world of Good Distribution Practice (GDP) has developed significantly over the past few years. There has been an increase in focus from many regulatory agencies including the MHRA. With Brexit still highly on the agenda, the result of the Brexit deal will undoubtedly have an impact on supply chains for pharmaceutical products sourced from the European Union and European Economic Area. The MHRA published guidance last year to clarify and support the pharmaceutical industry and importers in the UK. RSSL recognises that there is a need to do more to assist industry in creating an environment that supports the role and responsibilities of Responsible Persons for GDP, Logistic Managers and other individuals involved in the pharmaceutical supply chain industry.

Although predominately aimed at Responsible Persons, this webinar will interest those who are working in Good Distribution Practice for medicinal products, employed by a company that has an MHRA/EU Wholesale Distribution Authorisation (WDA) license. If you are looking for an update to your existing knowledge, in particular relating to the latest current regulations in GDP, with the opportunity to ask questions and share best practice ideas whether you are an RP, Deputy RP, Quality Manager, in a QA Regulatory/Compliance or Logistics role, we would welcome your participation in this forum.

Each month has a defined topic, as follows :

• January 2024 – GDP Inspection Reports Review - Learning from the mistakes of others.
• March 2024 – Master data and Control of Supply, its role in GDP
• May 2024 – Management of Outsourced Activities – Best Practice and Compliance Risks
• July 2024 – Qualification and Validation of equipment and processes
• September 2024 – Preparation for the Windsor Protocol
• November 2024 - Hot topics tbc