Pharma Distribution Consulting Limited

​ ​Independent expert guidance on complying with Good Distribution Practice Guidelines and Human Medicines Regulations

       Expertise 

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• Former MHRA Expert GDP Inspector and  GDP Lead for the Inspection Action Group (IAG) and Compliance Management Team (CMT) from 2015 to 2021.

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• Responsible for GDP Inspection strategy, development of the risk based inspection programme. GDP Lead for FMD guidance and implementation. 

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• GDP EU Exit Lead, provided the guidance for import from approved countries, the RPi and supply to Northern Ireland.

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• Part of EMA GDP working group for drafting GDP Guidelines and EU Community Procedures and a member of the PIC/S GDP working group. 

• GDP Lead for Covid 19 vaccine deployment and author of the temporary GDP flexibilities created in response to the pandemic.

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• Supply chain security, due diligence of customers and suppliers,  identification of suspicious transactions.  Worked closely with DHSC on the Export ban policy and implementation. 

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• Provided GDP training for international regulators, US FDA, Swiss Medic and Asia Pacific nations. Presenting to industry at MHRA Symposium and commercial events on GDP and Human Medicines regulation requirements.

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• Responsible for the accreditation of new GMDP inspectors  for authority to inspect.

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• Provided training for consultants applying to be deemed eligible as MHRA Compliance Monitors