Compliance matters
GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licencing requirements and general handling of Investigational Medicinal Products (IMPs). …
There has been much discussion of late between regulators and industry on how we can ensure that patients and the public get new medicines as quickly as possible - all the way from development to regulatory approval - while still …
This is the second part a two-part blog series on the Compliance Monitor Process which is being piloted by the MHRA from April 2022. As outlined in the first part of this blog, the MHRA is starting a pilot in …
This is the first part of a two-part blog series on the Compliance Monitor process which is being piloted by the MHRA from April 2022. The MHRA has a history of implementing risk-based inspection practices: 2009: The risk-based inspection programme …
New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European Union, and with it, the Commission guidelines on good manufacturing practice for investigational medicinal products for human …
The MHRA GPvP Inspection Metrics report for the period April 2020 to March 2021 is now available. Read the full metrics report published on GOV.UK. We hope that the report is informative and useful for considering compliance and improvements within …
A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.
A link to the MHRA webinar of 13 August 2021 and updated information addressing some key questions received during this webinar
Members should conduct a documented review of their existing data integrity processes against the new OECD document to ensure that they fully comply and any required changes or additions are implemented.
Following the February 2020 MHRA and FDA GCP symposium in London, our second joint paper is now available.
