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Compliance matters

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'

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice
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.

Good Clinical Practice Symposium 2020

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good clinical practice
Good Clinical Practice Symposium 2020

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: , Posted on: - Categories: Compliance matters, Events and symposia, Good laboratory practice
The GLP Team at the 2020 symposium

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

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Lady with a face mask and virus particles representing Covid infront of her

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.