Restrictions in IGJ on-site inspections due to safety risks
During national or international crises, on-site GxP inspections may not be possible for a number of reasons such as travel restrictions, risks to health, or other restrictions/guidance issued by local or national authorities. During these situations, the obligation of the site/facility to comply with GxP is not waived and the ongoing verification of compliance by Supervisory Authorities is important to ensure the protection of public health.
In general, IGJ bases its decision on travelling to third countries to conduct an inspection, on the formal travel advice of the Ministry of Foreign Affairs. We assess the safety- and health risks and obey the national and local Covid-19 rules. Furthermore, a country and specifically the site, must be accessible with normal transportation.
These limitations are applicable to all IGJ inspections performed in third countries. Inspections that may be affected by these limitations include inspections on adherence to Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) and Good Manufacturing Practices (GMP).
IGJ will consider on a case-to-case basis alternative methods to assess the compliance level of a site or study such as a distant assessment. However, a distant assessment does not replace an on-site inspection and IGJ follows EMA Guidances on distant assessments. Other possibilities are currently explored together with EMA and the Medicines Evaluation Board.
Every three months IGJ will evaluate the limitations for travelling to third countries and adapt its policies wherever possible. IGJ will continuously monitor the situation. We hope that there will be arrangements or significantly lighter restrictions in the near future, to allow inspectors to conduct on-site inspections again in third countries that currently cannot be visited due to travel restrictions.
Most inspectorates/national authorities are reluctant to send inspectors to countries with restrictions for travelling. The EMA has issued a Q&A about the impact of the pandemic on a.o. inspections.