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.
We often receive questions about GCP training for laboratory staff, which suggests that this is a topic that causes quite a few laboratories issues!
Q&As clarifying expectations for implementation of the HBEL guide and cross-contamination control requirements were published in April 2018
An update on staff changes within the Inspectorate
A joint MHRA/HRA statement has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods.
Part two of this post provides two case studies from inspections where critical and major findings have been identified in regards to Organisation’s Oversight of Clinical Trials of IMP.
On the 5 and 6 September, the GCP Inspectorate held their symposium and were joined by colleagues from the FDA, the Brazilian authority ANVISA and the Israeli Ministry of Health.
The GPvP webpage has recently been updated to provide additional information about the current inspection process. This post provides some further information about GPvP inspectors and inspections.
This is the final of three posts centered around the Responsible Person named on a Wholesale Distribution Authorisation (WDA) and covers the engagement of a contract RP
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
The first of two posts focusing on sponsor oversight and how to improve compliance in this area.
