GOV.UK
2018 MHRA Laboratories Symposium
The Inspectorate laboratories group conducts a diverse number of inspections both internationally and across the United Kingdom.
Good manufacturing practice
EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase
Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
International regulators inspecting in the UK
The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.
PIC/S - Press release and news of TFDA hosted meetings and seminar, September 2017
From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)
Potential supply issues
The last couple of months have seen some catastrophic weather conditions across the globe. These can have a significant impact upon the pharmaceutical supply chain.
Missed our last few posts?
A bite sized summary of our recent posting to the MHRA Inspectorate blog
Annex 16 QP Certification and Batch Release – Frequently Asked Questions – part 2
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)
Do wholesale distributors require pharmacovigilance agreements?
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
An Inspector Calls: Part 1, GMP Short Notice and Unannounced Inspections
An update on the use of short notice and unannounced GMP inspections
Use of Freezers
This post describes the main issues seen when freezers are used by pharmaceutical wholesalers and provides an MHRA GDP inspectors’ view on possible ways to address them.