Members should conduct a documented review of their existing data integrity processes against the new OECD document to ensure that they fully comply and any required changes or additions are implemented.
Good laboratory practice
Guidance for manufacturers and contract testing laboratories on the process of transferring a method for outsourcing of testing
The start of lockdown this time last year meant a complete change to the way of working for the inspectorate, with the potential to impact dramatically on our ability to maintain regulatory oversight of public health
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
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.
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.
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.
Have you ever thought about becoming an MHRA inspector but wanted to know more about the role, the application process, or the benefits associated with joining a talented and dynamic team protecting public health? Part one of this two-part blog will hopefully give you the information you need to consider for applying for future roles.