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.
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.
The MHRA are holding a GCP Stakeholder engagement meeting on 16th November at our offices in London in order to explore 3 areas of the new Clinical Trials Regulation that require national legislation.
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)
Are you a new applicant establishing a small wholesale dealers’ operation; and do you need guidance for creating written procedures?
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
Last week we published the 1st April 2015 to 31st March 2016 GCP Inspection metrics report.
To help GLP organisations pro-actively improve compliance we are sharing the 2015 inspection metrics and examples also seen over the last 12 months