GDP Audits & Inspections

To Master GDP Audits conducted by the MHRA is to achieve a level of expertise and control that ensures seamless regulatory compliance and ensures patient safety, the ultimate goal of GDP activities! 

MHRA Inspections are critical assessments of your pharmaceutical distribution practices, and mastering them requires a thorough understanding of GDP related regulations and guidance and a proactive approach to compliance which is systematic throughout your organisation. 

Understanding Regulatory Compliance is the cornerstone of your mastery.

The MHRA’s “Guidelines on Good Distribution Practice of medicinal products for human use” (EU GDP Guidelines, adopted by the UK) otherwise known as the ‘Green Guide’ are your definitive guide. Failure to adhere to these guidelines can result in serious repercussions, including financial penalties, license revocations, and legal action. 

Strategic Mastery: Building a Robust Compliance Framework

Compliance begins with the development of a strong quality management system (QMS) that not only meets but exceeds MHRA standards. This involves meticulous documentation of all procedures, processes, and records.

A comprehensive GDP Compliance Checklist which is compiled with all of your licensable activities in mind, is your essential tool, ensuring that no aspect of compliance is overlooked.

Key areas include:

• Temperature Monitoring and Control:
  Achieving precision is crucial. MHRA data indicates that temperature excursions are a significant cause of non-compliance, affecting approximately 30% of inspections. Your medicinal product storage areas should be temperature mapped to ensure medicinal products are stored in areas most appropriate for their documented storage requirements and continuous temperature monitoring should be in place.
  
• Secure Storage and Handling:
  Implement robust security measures to prevent unauthorizsed access to your medicinal products and ensure proper product segregation ensuring there is a clear definition between products that have been released to saleable stock and those that are pending a final decision on their disposition. 
• Documentation and Record-Keeping:
  You must ensure you maintain meticulous records of all GDP activities, as inadequate documentation contributes to nearly 40% of GDP non-compliance findings.  Documents must be retained for a minimum of 5 years and must be readily accessible and available.
• Personnel Training and Competency:
  It is a GDP requirement that all staff involved in GDP activities are highly skilled and knowledgeable and that their competency levels have been assessed BEFORE they undertake GDP related activities. Comprehensive training can reduce personnel-related non-compliance by up to 25%. 

Transforming Common GDP Audit Findings into Compliance Wins

By proactively performing self-inspection audits and addressing areas of non-compliance, you can significantly reduce the risk of non-compliances of a serious nature being noted by an MHRA inspector during your regulatory inspections. 

Ensure you maintain impeccable documentation at all times, including detailed records of temperature logs, stock control, and distribution activities, ALCOA principles should be applied to all GDP related documentation. 

Implement a robust CAPA system to promptly address any non-compliance issues and be sure to monitor any implemented CAPAs for effectiveness. 

Continuous improvement is essential for ongoing compliance. Regularly conduct internal GDP audits and self-inspections to identify and address potential issues. 

Leveraging Expertise

Invest in comprehensive training to ensure your staff is highly competent and be sure to document training and outcomes including competency levels.
For expert GDP training covering a wide range of topics, visit gdptraining.co.uk.

If you are unsure as to whether your current QMS and GDP activities comply with all GDP regulatory requirements, or if you need support with updating your systems into compliance following a regulatory inspection, it is highly recommended that you partner with experienced consultants such as Paradigm Shift Consulting to help you navigate the complexities of GDP.

For expert quality management systems support, including full GDP audits and gap assessments, visit paradigmshiftconsulting.co.uk.

For regulatory guidance, refer to the MHRA website: Medicines and Healthcare products Regulatory Agency (MHRA). Review the free EU GDP Guidelines as adopted in the UK, found through the MHRA website or obtain a copy of the MHRA Green Guide (2022) which incorporates the EU guidelines and provides additional information which can be useful when developing and maintaining a QMS.

For detailed inspection standards, visit: MHRA Inspections and Standards. And for further GDP information, check the UK GDP Association CIC: UK GDP Association who offer a wide range of support and GDP related templates for its members. 

Contact the Paradigm Shift team today for more information on how our team of consultants can assist you with your GDP activities and compliance levels.