A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.
We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The …
In January 2015, MHRA published guidance to ‘specials’ manufactures, to provide an interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers. The GMDP Inspectorate have been concerned that some Specials manufacturers have not always been receiving written orders …
The GLPMA website has been updated recently to include two new documents, a summary of inspection findings from 2014 and a guidance document relating to the use of test sites that have not been inspected by their national GLP monitoring …
In October 2015 a number of MHRA GCP Inspectors attended the GCP Inspectors Working Group Workshop hosted by the European Medicines Agency (EMA) in London. This is an annual training event originally held for EU Good Clinical Practice (GCP) Inspectors that …
We have recently had a number of situations where companies have not understood the obligations placed on them by the Human Medicines Regulations 2012 Regulation 44 (2) and (3) and Good Distribution Practice in relation to qualification of suppliers. In …
Not to be outshone by our GDP colleagues, this post is to communicate the highlights from the GMP days at the 2015 MHRA Symposium. I’m Michelle Rowson, a GMDP Operations Manager, and part of my role is to lead in planning …
Welcome to the latest MHRA GDP blog post! I’m Claire Glenister, a GDP Inspector who has been working for the agency for 3 years. This blog is to communicate highlights from the 2015 GDP days at the MHRA Symposium, at …
My name is Balall Naeem and I have been with the MHRA for more than 10 years now. In that time, I have worked across 3 different Divisions in a number of roles. The ones most relevant for this topic would …
We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The …
Late last year the GPvP inspectorate ran its own symposium and contributed heavily to the EU pharmacovigilance inspector training event. GPvP symposium The GPvP inspectorate held a sell-out symposium in London in November attended by approximately 350 delegates. GPvP inspectors highlighted requirements, …
