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 …

MHRA support for innovation - Inspectorate input to case studies

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

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

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 …

Importation of unlicensed medicines and centrally authorised products - a helpful reminder

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 …

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 2

Data charts on a screen

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 …