9/10 September 2021
While the FDA and other inspectorates have cancelled on-site inspections for the duration of the outbreak of Covid-19, many have started performing remote inspections for selected sites.
In the EU for example, the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the EU. In an Q&A document, it is stated that for new sites/facilities, a "distant assessment" conducted by an EU/EEA competent authority may be an option. A GMP certificate may then be "granted depending on the outcome of the assessment".
The U.K. MHRA has published their thoughts in a blog on "MHRA Good Practice (GxP) inspections during the COVID19 outbreak". The MHRA itself will "focus on service continuity by using alternative approaches for routine regulatory oversight, such as office-based assessment and the sharing of information within the international regulatory network".
Currently FDA is utilizing and implementing "additional alternative inspection tools and approaches" while still postponing domestic and foreign routine surveillance inspections .FDA still doesn't know when to return to on-site facility surveillance inspections but is discussing a possible process "that would govern how and where to return to on-site facility surveillance inspections".
Now, the Australian Therapeutic Goods Administration (TGA) has published a media release stating that they have started to undertake "remote and/or hybrid GMP domestic inspections" in place of on-site inspections. These will be performed during the COVID-19 pandemic. On-site inspections will start again after the pandemic restrictions are lifted.