I joined the MHRA as a GMDP Inspector in January 2013. My position involves inspecting domestic and overseas manufacturers and also UK importers. I previously worked in the pharmaceutical industry for 19 years, where I held roles in a number of areas including development, scale-up, process validation, outsourcing, regulatory affairs and QA.
This is the second part a two-part blog series on the Compliance Monitor Process which is being piloted by the MHRA from April 2022. As outlined in the first part of this blog, the MHRA is starting a pilot in …
This is the first part of a two-part blog series on the Compliance Monitor process which is being piloted by the MHRA from April 2022. The MHRA has a history of implementing risk-based inspection practices: 2009: The risk-based inspection programme …
Earlier this year I posted the first part of 'Around the world in 80 ways' focussing on API supply chains. Here as promised is part 2.
The supply chain for Active Pharmaceutical Ingredients (APIs) has been increasing in complexity for a number of years with the potential for a number of players to be involved, with multiple possible routes around the world available (significantly more than …
