Year: 2019

  In November 2017, the MHRA released a document that contained deficiency data from inspections carried out in 2016. It included the most common areas of deficiencies found during inspections in relation to the GDP EU Guidance 2013/C 343/01, as well as examples of deficiencies from each chapter.  The data showed that the top deficiency areas…

Since the approval for specialist prescribers to write scripts for CBPMs (Cannabis based medicinal products) was given for 01 Nov 2019, there has been a flurry of activity to get licensed. Paradigm Shift have had multiple enquiries about licensing for the procurement and supply of CBPMs, and are working with a number of companies in…

The mention of the IAG can strike fear into the hearts of many wholesalers… usually those who are not compliant with GDP. So, who are the IAG? The letters IAG stand for “Inspection Action Group” and they’re a multidisciplinary team that are part of the MHRA. IAG 1, responsible for GDP, GMP and blood banks meets…

Starting in February (2019) we are extending the duration of our training courses so that they will now run for two days instead of one. Day One will be an intensive session that covers all chapters of the EU Guidance, expectations of the MHRA, bona fides, deviations, CAPA, Change Control and Complaints. This is an…

Holders of a Wholesale Distribution Authorisation (Wholesale Dealer Authorisation) can be suspended for a number of reasons, but most commonly to regulatory action from the MHRA (Medicines and Healthcare products Regulatory Agency). Paradigm Shift Consulting have worked with many customers who have experienced MHRA regulatory action resulting in suspension of the licence and being listed on the public MHRA Suspended…

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