If medicinal products are to be of the quality consumers and regulators expect, then the active substances within them need to be manufactured in accordance with Good Manufacturing Practice and their quality and integrity maintained throughout the supply chain through the application of Good Distribution Practice (GDP). In Europe, the Falsified Medicines Directive (2011/62/EU) amended... Read more

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 Covid-19 situation, the organisers of Making Pharmaceuticals have reluctantly decided not to go ahead with the rearranged dates of 26/27 October 2020, but will now not hold a physical event at the Ricoh Arena until July 2021.  However, a series of webinars will now be arranged.  Keep an eye on the Making Pharmaceuticals... 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