The inspections that Swissmedic carries out under therapeutic products legislation are one of the many things affected by the COVID-19 pandemic restrictions. At the end of March 2020, Swissmedic announced that it was suspending routine inspections until the end of April. Following the Federal Council’s decisions to gradually relax measures to contain the pandemic, Swissmedic is adapting its practice. On-site inspections will be resumed in stages in consultation with the establishments being inspected and in compliance with official hygiene and conduct rules. However, remote assessments may also take place until further notice. This involves an IT-based review of documents or operational processes and videoconference discussions between review participants and inspectors.
Swissmedic is adapting its therapeutic products sector inspections practice
07.05.2020
Principles
A risk assessment will be carried out before every scheduled inspection. Depending on the outcome, inspections may be postponed to a later date, conducted on site – in which case the recommended protective measures will be observed – or conducted remotely. Non-routine, unscheduled, for-cause or routine, scheduled, process-specific safety assessments will generally take place on site and the necessary protective and hygiene measures will be observed.
Medicinal products sector inspections and inspections of transplant and transplant product handling
Swissmedic inspections associated with establishment licences issued under the Therapeutic Products Ordinance (TPO)
Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) inspections
Inspections may be conducted on site by arrangement and subject to strict compliance with all necessary protective and hygiene measures. Where inspections are relevant for GMP/GDP certificates and are conducted remotely, a note to this effect will be added to the certificates in keeping with the approach defined by the EMA. The same applies by analogy to inspections relating to transplant product, autologous transplant and allogeneic transplant handling under the Transplantation Act.
GLP inspections
Inspections of assessment facilities and trial audits in accordance with the Ordinance on Good Laboratory Practice (OGLP) will be planned and conducted in consultation with the competent GLP unit and the affected assessment facilities from the Swiss GLP monitoring programme.
Inspections of microbiological laboratories
On-site inspections of microbiological laboratories will be resumed in stages. As it resumes inspections, Swissmedic will take particular care to ensure that no unnecessary additional workload is created for laboratories associated with hospitals. During this period, alternative forms of assessment (e.g. desktop assessments) will continue.
Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) inspections
Inspections of clinical trials involving transplant products
Inspections of clinical trials involving therapeutic products and transplant products and inspections of pharmacovigilance systems will be resumed in stages. As it resumes inspections, Swissmedic will take care to ensure that no unnecessary additional workload is created for hospitals in particular during the COVID-19 pandemic. It is currently not known when inspections in hospitals and academic settings will resume, as this will depend on the pandemic situation in each. Company inspections may resume at an earlier date.
Medical devices sector inspections
Market surveillance
A risk assessment is carried out before every inspection. For-cause inspections that are essential on product safety grounds will take place on site, and the recommended protective and hygiene measures will be observed.
Monitoring clinical trials of medical devices in humans
Inspections of clinical trials will be resumed in stages. The date on which inspections will resume in hospitals and academic settings will depend on the pandemic situation in each. If necessary to ensure the safety of trial participants, for-cause inspections may be carried out regardless of the pandemic situation.
Inspections of reprocessing, maintenance and notification processes in hospitals
Inspections will be resumed in stages from June 2020. Scheduling will take account of each hospital’s COVID-19-related workload. Each scheduled inspection will be discussed with the people concerned.
Quality assurance
Swissmedic reminds manufacturers and facilities that they are responsible for ensuring that the quality of their products and services complies with the relevant requirements.
Inspections in compliance with necessary protective and hygiene measures
If inspections are carried out on site, participants must organise the necessary precautions for the inspections (meeting rooms with sufficient space, restricting participant numbers, providing electronic resources such as projectors for document assessment, etc.) Face masks must be worn if it is not possible to comply with social distancing rules.