MHRA and US FDA tackle challenging data integrity
MHRA and US FDA tackle challenging data integrity
Following the February 2020 MHRA and FDA GCP symposium in London, our second joint paper is now available.
Post-transition: Pharmacovigilance requirements for UK authorised products - Thursday 22 October 2020
Posted by:
Kiernan Trevett, Emily Cannell and Anne Ambrose, Posted on:
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Categories:
Compliance matters, Events and symposia, Good pharmacovigilance practice, Wider MHRA
Post-transition: Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 22 October 2020. This webinar was part of a series of EU Exit and post-transition guidance webinars.
Qualifications of suppliers and customers online: reliable or fake news?
Posted by:
Emanuela Krasteva and Peter Brown, Posted on:
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Categories:
Compliance matters, Good distribution practice
The need for vigilance and diligence when conducting bona fide checks is integral to protecting the legal supply chain of medicines. What to look out for and how to report any suspected fraudulent activity
Professor Taylor on being the Chair of The British Pharmacopoeia Commission
The BPC is looking to appoint a new Chair from October 2021. The current Chair, Professor Kevin Taylor, shares some of the highlights and achievements of the past 8 years, and we launch the process of finding his successor.
Building resilience into clinical trial design and conduct during the pandemic
Posted by:
Gail Francis and Martin O'Kane, Posted on:
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Categories:
Compliance matters, Good clinical practice
Updated guidance is now available to assist trial sponsors in building resilience into new and ongoing trials during the continuing pandemic.
A fresh look at an old topic: Investigations in the GMDP environment
Posted by:
Callum McLoughlin, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
Investigations are an inevitable aspect of any manufacturer’s or wholesaler’s operations. We share some common issues seen at inspections so you can consider your own company’s systems and practices and improve investigation outcomes.
Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.
Posted by:
Graeme McKilligan, Posted on:
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Categories:
Compliance matters, Good manufacturing practice
During this period where MHRA has been conducting predominantly remote inspections, we have reflected on some of the common factors in critical deficiencies we have been seeing in control strategies for cross contamination between products in shared facilities.
GCP Serious Breaches update
A look at the Serious Breach data for 2019 plus details of update to the notification form and guidance documents
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.
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