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Windsor Framework & Pharma | GMP, Brexit & Regulatory Impact Explained @HelpMeGMP

The Windsor Framework has significantly reshaped the landscape for pharmaceutical companies operating between the UK, Northern Ireland, and the EU. In this detailed video, we clearly explain what the Windsor Framework means for the pharmaceutical industry, particularly in relation to GMP (Good Manufacturing Practice), regulatory compliance, and the implications of Brexit.

We’ll discuss how these regulatory changes affect pharma supply chains, GMP inspections, quality assurance practices, and the everyday compliance responsibilities for manufacturers, distributors, and regulatory professionals. Whether you're based in the UK, EU, or globally, understanding the Windsor Framework is essential for continued compliance and successful pharmaceutical operations.

*What You'll Learn in This Video:*

An easy-to-follow explanation of the Windsor Framework and its purpose
How the Framework affects GMP compliance and regulatory inspections (MHRA, EMA, FDA)
Changes to the movement, testing, and release of medicines between the UK, Northern Ireland, and the EU
Practical guidance for pharmaceutical companies to maintain regulatory compliance post-Brexit
Real-world implications for pharma manufacturers, Quality Assurance (QA) professionals, and logistics teams

*Why is the Windsor Framework Important for GMP?*

The Windsor Framework was established to address complex regulatory and trade issues caused by Brexit, particularly affecting Northern Ireland. For pharmaceutical companies, this means adapting quickly to ensure seamless GMP compliance across different regulatory jurisdictions. Misunderstanding or ignoring these changes can lead to delays in product approval, import/export issues, non-compliance notices, product recalls, or even regulatory sanctions.

*Who Should Watch This Video?*

Quality Assurance (QA) and Quality Control (QC) professionals in pharma
Regulatory Affairs specialists navigating UK/EU regulatory requirements
Pharmaceutical manufacturers and distributors affected by Brexit
Supply Chain and Logistics managers responsible for medicine distribution
Senior management in pharma companies managing regulatory risk

*Key Topics Covered in the Video:*

Clear overview of the Windsor Framework: What exactly changed?
GMP implications and compliance strategies post-Windsor Framework implementation
Impact on Qualified Person (QP) batch release and import/export testing
Changes to Northern Ireland Protocol and their impact on pharma logistics
Guidance on managing regulatory expectations from MHRA, EMA, FDA, and EU member states
Strategies for ensuring regulatory alignment, reducing compliance risks, and maintaining smooth product supply chains

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*Why Choose Help Me GMP?*

At Help Me GMP, we simplify complex pharmaceutical and GMP compliance topics into easy-to-understand resources, providing you with actionable insights and practical training to enhance your compliance knowledge. Our mission is to support professionals globally, offering free GMP training to ensure product quality, patient safety, and regulatory excellence.

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*Subscribe* to Help Me GMP for regular, free GMP training content
*Like & Share* this video to help colleagues understand the Windsor Framework
*Comment Below:* What has been your biggest challenge adapting to the Windsor Framework?


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Stay informed, compliant, and prepared with Help Me GMP. Join the conversation and let us know your thoughts or questions about the Windsor Framework and its impact on your pharmaceutical operations.