Good distribution practice
We have recently had a number of situations where companies have not understood the obligations placed on them by the Human Medicines Regulations 2012 Regulation 44 (2) and (3) and Good Distribution Practice in relation to qualification of suppliers. In …
Not to be outshone by our GDP colleagues, this post is to communicate the highlights from the GMP days at the 2015 MHRA Symposium. I’m Michelle Rowson, a GMDP Operations Manager, and part of my role is to lead in planning …
Welcome to the latest MHRA GDP blog post! I’m Claire Glenister, a GDP Inspector who has been working for the agency for 3 years. This blog is to communicate highlights from the 2015 GDP days at the MHRA Symposium, at …
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 …
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 …
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 …
We have recently had a number of situation where importers of unlicensed medicines have attempted to notify MHRA of centrally authorised products for import as unlicensed medicines. This is not appropriate, as these are not unlicensed medicines and should be distributed …
A highlight of our work is when we get to engage with you through our symposia. It is a rewarding opportunity for us to keep many hundreds of you – our stakeholders - up to date with the latest regulatory …
