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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

Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager.   In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

Our 2-day course is updated for Annex 1 changes

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