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
Good distribution practice
The need for vigilance and diligence when conducting bona fide checks is integral to protecting the legal supply chain of medicines. What to look out for and how to report any suspected fraudulent activity
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.
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
Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation.
During the Covid-19 pandemic you may need to adjust how you operate. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles.
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.
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.