A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.
In may, the GPvP Inspectorate held their symposium, which provided a platform for information sharing and discussion between inspectors and assessors from the MHRA and industry colleagues working within pharmacovigilance and associated departments.
This is the first in a set of three posts centered around the RP named on a WDA. This post provides information on external training recognition and training providers. The second of these three posts aim to enhance the appointment of the RP and the third post will place a particular emphasis on the engagement of a contract/consultant RP.
Find out how to register for the 2018 GCP Symposium.
Guidance and examples of data integrity issues seen on GDP inspections.
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
The GDP inspectorate has seen a growing number of false NHS and private prescriptions being used to obtain medicines from Marketing Authorisation Holders for the onward wholesale.
This post provides guidance around the use of VHP for sterilization purposes
This post provides guidance around the urgent supply of unlicensed medicines that have needed to be imported out of hours by UK hospitals.
This post provides some background information to the aims of the operational transformation programme and how the inspectorate is rising to the challenge.
The MHRA’s GXP data integrity guide has been published today.
