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GPvP inspections of contract service providers

Posted by: and , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice
Capsule broken open with images of heath spilling out

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 …

GMP Inspectorate: blood compliance report assessment process

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice
Blood transfusion bag

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 …

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

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
Tablets in many colours

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

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice
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 …

Educating and engaging through our symposia

Good Clinical Practice Symposium

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 …