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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 …

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 3

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice
Vials in a laboratory

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. A robust data governance approach will ensure that data is complete, consistent and accurate, irrespective of the format in which data is …

MHRA support for innovation - Inspectorate input to case studies

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice, Inside the Inspectorate
Clockwise from top left. Images courtesy of: The Cell Therapy Catapult; BTG Plc; AstraZeneca; Fujifilm Diosynth Biotechnologies; Eisai.

MHRA has now published 7 case studies highlighting the work of our Innovation Office and showing how we help organisations that are developing innovative medicines, medical devices or using novel manufacturing processes to effectively navigate regulatory processes, so they can progress their products …

The British Pharmacopoeia's new website - setting the standards

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice, Inside the Inspectorate, Wider MHRA

The launch of the new integrated British Pharmacopoeia website this week presents a great opportunity to explore this other group within the Inspection, Enforcement & Standards Division of MHRA. The British Pharmacopoeia (BP) makes an important contribution to the role of MHRA …

GPvP inspections of contract service providers

Posted by: and , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice
Capsule broken open with images of heath spilling out

The Medicines and Healthcare products Regulatory Agency (MHRA) has embarked on a recent initiative to evaluate the feasibility of conducting stand-alone inspections of pharmacovigilance contract service providers. In July 2003 MHRA introduced a statutory pharmacovigilance inspection programme of marketing authorisation …