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Compliance matters

Transitional QPs for investigational medicinal products (IMPs)

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice
QP using laptop in office

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 …

The GPvP inspectorate promote compliance and best practice at 2 successful events

EU Inspector Training: GPvP Inspectors from the MHRA, EU and beyond and EMA staff who coordinated the event.

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, …

Refrigerated medicinal products, part 1: receipt and storage - some things to consider

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
Industrial cold store scene

Patient safety is the end objective for manufacturers, wholesalers, distributors and those healthcare professionals administering to patients. This blog is in 2 parts and draws on some of the findings from good distribution practice (GDP) inspections, references to the EU GDP …

MHRA GPvP Inspection Metrics for April 2014 to March 2015

Posted by: , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice
Individual studying metrics

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period of April 2014 to March 2015. The full metrics report is available on GOV.UK. The report concludes that in the period April 2014 to March 2015, MHRA conducted a …

PIC/S - Press release and news of MHRA chair in 2016/17

Attendees at the 2015 PIC/S Annual Seminar, Indonesia

Back in October I attended, with MHRA colleagues, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) committee meeting and annual seminar that was this year hosted by the Indonesian National Agency for Drug and Food Control (NADFC). In the new year I'll …

Helping us to help you – 5 top tips for making enquiries to the MHRA Inspectorate

Helping us to help you by a) check our blog/pages of the website, b) be specific by which GXP your query relates to c) be specific about what your query relates to d) be specific about which company/site your query relates to e) give your proposal of what you intend to do

The MHRA Inspectorate receives several hundred enquiries via email each year. Answering queries is one of the key ways we support industry. It provides reassurance to our stakeholders, aiding them in their decision-making processes, helping to ensure they don’t fall …

Defective Medicines Report Centre (DMRC): an overview of our work

Posted by: , Posted on: - Categories: Compliance matters, Inside the Inspectorate, Wider MHRA
Members of the DMRC team at MHRA

Joiners and leavers Those of you that have contacted the Defective Medicines Report Centre (DMRC) recently may have encountered some new names – I started as manager of the DMRC team in early April, joining Christine Cox and Alison Bunce. Also …

Supply of unlicensed medicines when an equivalent licensed product becomes available

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
blister pack

We've had a number of instances where licensed versions of commonly supplied unlicensed medicines have become available.  We want to remind stakeholders what to do if this happens. Recent examples of newly licensed products of this nature include fomicyt, 40mg/ml fosfomycin …