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Post-transition: Pharmacovigilance requirements for UK authorised products - Thursday 22 October 2020

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?

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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

A fresh look at an old topic: Investigations in the GMDP environment

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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.

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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.

MHRA planning for return to on-site Good Practice (GxP) inspections

Virus Particles

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

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Scrabble pieces making up the word 'risk'.

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'

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Group photograph of MHRA GCP inspectors and US FDA

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.