23/24 September 2021
A blog by Paula Walker, Inspectorate Operations Manager at the UK Medicines and Healthcare products Regulatory Agency (MHRA), provides interesting insights into the agency's current inspection practice. With over 750 GxP inspections conducted remotely, a lot of experience has been gained here within one year. This experience has also been shared through the International Coalition of Medicines Regulatory Authorities (ICMRA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), including training of other regulatory authorities.
The start of global lockdowns less than a year ago completely changed the way inspections work. Although some activities had already been carried out remotely before the pandemic, most inspections took place on site. But now a variety of methods had to be established within a very short period of time in order "to enable regulatory oversight of patient and public health and security of the global supply chain". And so, within the first month, remote inspections took place in all GxP areas. Various file-sharing platforms were tried and established for this purpose.
One outcome that was unexpected is that distant assessments actually take longer than on-site inspections. Even the best technology does not guarantee "real time presence of questions raised and answered". Nor does it allow to "dig around" to see what the compliance level of a facility really is. So while the distant assessment capability is a great "tool" in the inspection toolkit, it can't really replace an on-site inspection. There are also areas that do not lend themselves to distant assessment; Paula Walker cites manufacturers of sterile pharmaceuticals as an example.
Since the time of a return to normal inspection operations is uncertain, especially for overseas inspections, the MHRA is trying to further improve the virtual methods, including the use of "visual technologies". These should make it easier to have a certain degree of "eyes on site" for crucial areas.
You will find further information in the MHRA Inspectorate Blog "Inspectors grounded - a year of innovation".