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Compliance matters

Pharmacovigilance requirements for UK authorised products - 13 January 2021

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Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars.

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?

Posted by: and , Posted on: - 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

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.

Posted by: , Posted on: - 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.