A number of recalls have occurred in the last two years following the finding of nitrosamine impurities in medicinal products, firstly the ‘sartans’ and then other products, notably ranitidine.  This has led to enhanced regulatory agency and pharmaceutical industry action to assess and manage the risks.  In Europe, a key element of this was the issue... Read more

The MHRA have created a collection on their website for information related to Covid-19.  Of particular interest to members will be information about clinical trials and MHRA services.  The collection may be found here. Separately, MHRA have issued a news release about the impact of Covid-19 on GxP inspections.  The headline message is that MHRA... Read more

With the ongoing development of the Covid-19 situation, the organisers of Making Pharmaceuticals have postponed from April to new dates on 26/27 October.  The venue will remain the Ricoh Arena.  See this announcement for further details.  PQG will plan to attend the new dates.   Read more

The European Commission has published the long-awaited draft Annex 21 on Importation of medicinal products. This is now open for stakeholder consultation until 20-Jun-2020. If you would like to feed comments in via PQG, then please email webmaster@pqg.org by end April. The document is only short (140 lines). It focusses on the action of physically... Read more