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.
Hello and welcome to Reference Safety Information II. Hopefully you will all have read my first Reference Safety Information (RSI) post which focused on how the RSI should be Identifiable, Approved and Consistent.
We currently have a vacancy for a pharmaceutical assessor to join the Defective Medicines Report Centre (DMRC) team, working closely with the Inspectorate as part of the Inspection Enforcement and Standards Division of the MHRA.
The 2015 GMP inspection deficiency data trend has been published yesterday
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
My name is Lynsay Hunter and I am the newest recruit to the MHRA laboratories inspection team, having previously worked in a variety of laboratory and quality assurance roles. My first MHRA event was the annual laboratories symposium held in …
The 2017 Orange and Green Guides are almost ready for publication.
Today sees the launch of the MHRA Blood Forum
The annual GCP Symposium was held by the MHRA on 20 September 2016 in Birmingham and was repeated on the 21 September 2016.
In October 2015 the MHRA was audited under the Joint Audit Programme (JAP) for EEA GMP Inspectorates.
