MHRA Inspections and Covid-19
MHRA have released a post describing their plans to return to onsite GxP inspections.
Click here to view the MHRA post
MHRA have been engaging with industry trade associations and the NHS to discuss the practical arrangements that may be required to facilitate on-site inspection starting in September and scaling up to a full programme from October 2020. Inspection conduct will vary according to the requirements of each GxP area and may include a hybrid model of on- and off-site activities that support a single inspection cycle.
Further information will be made available later in the summer. Until the full programme resumes, MHRA will continue to conduct its current COVID19 programme of remote assessment.
During the C-19 pandemic, Diamond have been continuing to support quality and compliance programmes globally. We have been actively embracing remote desktop audits to overcome the restrictions for onsite audits during this time. Notably we have provided desktop audits in India, Austarlia and USA by developing a robust process that meets the needs of clients and regulators.