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 …
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 …
Welcome to this, the next Inspectorate post. My name is Madeleine Ault and I have been with MHRA for over 6 years now. In that time I have inspected a wide range of wholesalers. These inspections cover large and small wholesalers, …
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 …
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 …
I am pleased to share the news that the UK Good Laboratory Practice Monitoring Authority's (UK GLPMA) guidance on the implementation and maintenance of a risk-based GLP quality assurance (QA) programme has been published. The GLPMA have for some time recognised there …
Welcome to the first of a series of posts from the GDP Inspectorate. In the last few years the world of GDP has changed in scope and complexity and continues to evolve to meet new challenges with the continued aim of …
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 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 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 …
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