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.
Good manufacturing practice
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.
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.
A principle objective of both the MHRA and of pharmaceutical companies is to protect and improve the health of patients. When new information about the benefits and risks of a medicine become available it is often appropriate to make changes to the safety information for the product.