The Belgian Monitoring Authority for Good Laboratory Practices is aware of the fact that the outbreak of COVID-19 presents challenges to all facilities in the Monitoring Programme. In response to the coronavirus outbreak, we have decided to suspend all on-site GLP inspections until further notice.
However, we do expect facilities to maintain GLP compliance and will continue our support to industry by using alternative approaches for regulatory oversight such as office-based assessments for facilities that approach the 3 year date since last inspection. An onsite facility inspection will then be scheduled once the regular inspection programme resumes.
In order to minimize the possible exposure to the coronavirus, facilities might have to alter/adapt their operation, but it is important that compliance with the principles of GLP continues to be maintained. In order to help facilities maintain compliance during this exceptional situation, we offer some guidance.
- Any issues encountered due to COVID-19 that could potentially impact the GLP status of a study should be managed, fully assessed and documented via existing amendment and deviation procedures.
- Facilities should promptly inform the GLP Compliance Monitoring Authority of any significant changes with regard to the premises, activities or management of a Test Facility.
- To maintain compliance, an adequate QA programme is essential. Therefore, it is strongly advised that QA programs prioritize all QA activities using a well-documented risk-based approach . This risk assessment can be used to identify where to focus resources and adapt audit programmes.
- When the amount of studies and the frequency of a critical phase allow to perform process based audits, the switch to process based audits should be considered to reduce the amount of study-based audits, also based on a well-documented risk assessment.
- The use of remote technology (video calls, pictures, …) can be considered as an alternative for QA activities instead of being physically present, on the condition that there is enough level of detail in the records (study records, pictures, videos …) to allow the reconstruction of the activities observed. The method of observations should be fully documented.
- The use of remote audits should be risk assessed completely to ensure there is a similar level of oversight as compared to a physical audit (and should be fully documented as well). The risk assessment should also describe what records are needed (and will be maintained) in order to allow full transparency and reconstruction of all remotely performed activities.
- For remote audits, all communication should be well documented. In case documents/records need to be transported from facility to the QA (remote / working from home) and back, an inventory of the moving in and out of these documents should be fully documented, with approval of the Study Director (in case of study records) and/or TFM (in case of facility records).
- In case paper records/documents are send electronically, the scanning process should be a verified process (verified copies) and documented as well.