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

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

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 …

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

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

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 …

Supply of unlicensed medicines when an equivalent licensed product becomes available

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

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 …