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.
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2018 to March 2019
The purpose of this post is to give an update on a change to how we are issuing our licences and certificates due to the coronavirus pandemic; and a reminder to keep your contact details up to date.
It is recognised that there are potential challenges specific to GLP facilities and studies at this time. The aim of this post is to provide you with information that will enable a flexible but compliant approach during this period.
The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work on industry, NHS and patients.
Following on from our previous post, further guidance has been published on our MHRA website in relation to Managing Clinical Trials and Clinical Trial Applications.
MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.
GCP inspections and how they are conducted has evolved over the years due to the increased complexity of trials, organisations, implementation of electronic clinical trial systems and the development of technology.
In the modern world it is increasingly common to see flexible, part-time or home working arrangements. The pharmaceutical industry is no exception, and with some companies employing a part-time or contract Qualified Person (QP), it is no surprise that the QP continues to play a key role even when away from the site.
The MHRA GMDP Symposium took place on 11 to 14 November 2019 in London and 26 to 27 November 2019 in Glasgow. The theme of the GMP event was ‘Control Strategies’, whilst the GDP days focussed on supply chain challenges faced by wholesalers.
In part 1 of the inspectorate recruitment posts, we provided information on the inspector role and recruitment process, part 2 provides more information on the benefits and opportunities available to MHRA inspectors.
