Good manufacturing practice
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 …
...samples) should be reported. Importantly, a sample of the product batch under test should not be used for the system stability check. An independent, well-characterised sample or standard will fulfil...
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 …
The good manufacturing practice (GMP) Inspectorate performs a varied role in ensuring both medicines and bloods are available and are of the right quality using a risk-based inspection programme. A programme for the inspection of manufacturer and wholesale dealer licence …
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 …
...The same alias or IT system log-in which cannot differentiate between different individuals should not be used. Legible (permanent): It should not be possible to modify or recreate data without...
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 …
Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.
