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.
Good manufacturing practice
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)
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.
A bite sized summary of our recent posting to the MHRA Inspectorate blog
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)
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
An update on the use of short notice and unannounced GMP inspections
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.
Earlier this week we published the 2016 GMP inspection deficiency data trend.
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 …