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Compliance matters

Risk-based GLP quality assurance programme

Posted by: , Posted on: - Categories: Compliance matters, Good laboratory practice
Scrabble pieces spelling out the word risk placed in a measure to detail measuring and managing risk

I am pleased to share the news that the UK Good Laboratory Practice Monitoring Authority's (UK GLPMA) guidance on the implementation and maintenance of a risk-based GLP quality assurance (QA) programme has been published. The GLPMA have for some time recognised there …

Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 3

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

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice, Inside the Inspectorate
Clockwise from top left. Images courtesy of: The Cell Therapy Catapult; BTG Plc; AstraZeneca; Fujifilm Diosynth Biotechnologies; Eisai.

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

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice, Inside the Inspectorate, Wider MHRA

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

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 …