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The MHRA have just released a quite lengthy article about the 2018 Good Distribution Practice (GDP) Symposium held in late November in London and Glasgow.

For those of you who did not attend the MHRA GDP event or missed the article the key highlights included:

  • an update for delegates on changes at the agency – including the successful completion of their move from Victoria to Canary Wharf and the latest news on their Operational Transformation programme.
  • a review of the EU Exit including the agency’s preparations for deal and no-deal scenarios
  • leading GDP Inspectors provided delegates with some real examples of the cost of non-compliance to companies. Their key take home message was “failure to act to identify and rectify non-compliance has consequences for patients, your company and you.”
  • the popular topic of the top deficiencies identified during GDP inspections involved data obtained from major and non-IAG referred critical findings. This data set reflects around 90% of UK distribution channels. The top five deficiencies were reported as follows:
    • Quality Management – Chapter 1 – 38% of inspections
    • Transport – Chapter 9 – 25% of inspections
    • Qualification of Customers – Chapter 5 – 20% of inspections
    • Returned Medicinal Products – Chapter 6 – 18% of inspections
    • Responsible Person – Chapter 2 – 15% of inspections
  • details of the requirements surrounding Active Pharmaceutical Ingredients (APIs) and when a registration is required.
  • outlining the requirements for implementing the ‘Safety Features’ element of the Falsified Medicines Directive, the recent consultation on the steps required for the UK to meet its obligations to transpose these provisions into UK law, and to review progress to date in implementing the European and National Medicines Verification Organisations (EMVO and SecurMed) and systems

To read the article on the MHRA GDP Symposium in full click here

You can see all of our articles on Responible Person/GDP click here

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