Previously, we have reminded importers of unlicensed medicines that Centrally Authorised medicines are the subject of Marketing Authorisations from the EMA, valid in all Member States and therefore cannot be notified for import into the UK as unlicensed medicines, unless …
Good manufacturing practice
The first post in this series described the importance of organisational behaviour on the success of data integrity control measures. Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.
A revision to chapters 3&5 of the EU GMP Guide including modifications to the control of cross contamination sections came into effect on 1st March 2015.
From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland
Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.
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.
In this post you’ll find the first in a series of ‘frequently asked questions’ related to the updated EU GMP Annex 16 on QP Certification and Batch Release.
Those of you who attended our symposiums in either Glasgow or London during December 2016 will have heard Jane Sewell – International Trade Development Liaison Officer from HMRC speak about the Unified Customs Code.
At the GMDP Symposium 2016, Andrew Hopkins and I gave a presentation about the Inspection Action Group (IAG) and Compliance Management Team (CMT), to highlight the systems and processes in place for when compliance issues are identified at manufacturing and …
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 …