Following the end of the COVID-19 public health emergency declared by WHO in May 2023, on-site GMP and GDP inspections were restarted after being postponed or carried out remotely during the pandemic. A number of postponed inspections still need to …
Good distribution practice
The first hybrid GMDP Symposium was held on 21-22 February 2023. For the first time, we offered delegates the opportunity to either watch the event online from the comfort of their homes or to join us in person in West …
A link to the MHRA webinar of 13 August 2021 and updated information addressing some key questions received during this webinar
The MHRA is inviting you to attend a free webinar as part of its commitment to providing guidance to industry and supporting stakeholders to prevent falsified medicines entering the legal supply chain.
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
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.