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
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.
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.
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
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.
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 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.
