Updated guidance is now available to assist trial sponsors in building resilience into new and ongoing trials during the continuing pandemic.
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.
A look at the Serious Breach data for 2019 plus details of update to the notification form and guidance documents
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.
Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.
Between 11 and 14 February 2020, the MHRA hosted a week-long series of events as part of the Good Practice Symposia Week. The week concluded with the second joint MHRA GCP and US Food and Drug Administration (FDA) event following that hosted by the FDA in the USA in October 2018, and the first one hosted by the MHRA in the UK.
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.
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.
Many marketing authorisation holders (MAHs) sponsor and run a wide variety of programmes that are often internally termed a ‘patient support programme’ (PSP) and we are often asked by industry about the expectations for the collection of safety data from these programmes.