In part 2 of our series on QP Certification and Batch Release we concentrate on the application of Annex 16 to Investigational Medicinal Products (IMPs)
From 10 April, we are removing .gsi from our email addresses. Technology has changed a lot since the introduction of the Government Secure Intranet (GSi) in 1996
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 …
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.
Risk minimisation measures aim to optimise the safe and effective use of a medicinal product throughout its life cycle.
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.
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.