Good distribution practice
Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners. In October 2016 I attended international data integrity workshops in China, hosted by CPAPE...
I am Bernadette Wilson a GDP Inspector who assisted with the organisation of the MHRA GMDP 2016 Symposium. I took to the stage for the first time this year to present on the topic of whistleblowing. I am pleased to …
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 …
In the October blog post we told you about the successful audit of the GMP Inspectorate under the JAP programme. Later that month the entire Inspectorate was assessed as part of the BEMA programme.
6 top tips for applicants submitting a Manufacturing Authorisation application or variation
The 2017 Orange and Green Guides are almost ready for publication.
