GCP Serious Breaches update
A look at the Serious Breach data for 2019 plus details of update to the notification form and guidance documents
Compliance matters
MHRA planning for return to on-site Good Practice (GxP) inspections
Posted by:
David Churchward, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice
On 23rd March 2020 MHRA I published a post outlining changes to MHRA’s GxP inspection programme during the COVID19 outbreak. This enabled industry and the NHS to focus on medicine supply and delivery of healthcare in support of the COVID-19 pandemic
A Practical example of applying Quality Risk Management in GDP – Transportation Risks
Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation.
MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'
Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.
Good Clinical Practice Symposium 2020
Posted by:
Rachel Mead, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice
Between 11 and 14 February 2020, the MHRA hosted a week-long series of events as part of the Good Practice Symposia Week. The week concluded with the second joint MHRA GCP and US Food and Drug Administration (FDA) event following that hosted by the FDA in the USA in October 2018, and the first one hosted by the MHRA in the UK.
Good Laboratories Practice Symposium 2020
Posted by:
Lynsay Hunter, Posted on:
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Categories:
Compliance matters, Events and symposia, Good laboratory practice
Between 11 and 14 February 2020, the MHRA hosted a week-long series of events as part of the Good Practice Symposia Week. This included individual events from the GPvP, GCP and Laboratories Inspectorates where a host of regulators and delegates from across the globe came together. Second on the week-long agenda was the laboratories symposium, running on the 12th February and attended by 315 delegates.
How to manage temporary GDP process changes and risks through the COVID-19 pandemic
During the Covid-19 pandemic you may need to adjust how you operate. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles.
Patient Support Programmes
Posted by:
Kiernan Trevett, Posted on:
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Categories:
Compliance matters, Good pharmacovigilance practice
Many marketing authorisation holders (MAHs) sponsor and run a wide variety of programmes that are often internally termed a ‘patient support programme’ (PSP) and we are often asked by industry about the expectations for the collection of safety data from these programmes.
Good Pharmacovigilance Practice Symposium 2020
Posted by:
Sarah Gomersal, Posted on:
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Categories:
Compliance matters, Events and symposia, Good pharmacovigilance practice
The Good Pharmacovigilance Practice (GPvP) Symposium 2020, held on 11 February in London and attended by 380 delegates, launched the weeklong series of events led by the Inspectorate as part of the MHRA Good Practice Symposia week.
Pharmacovigilance Inspection Metrics April 2018 to March 2019
Posted by:
Sophie Radicke, Posted on:
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Categories:
Compliance matters, Good pharmacovigilance practice
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2018 to March 2019
Related content and links
