The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
Office Based GLP Inspections
If an office based inspection of your facility is conducted, once the inspection is closed a statement of compliance will be issued to provide your facility with a record of continued membership of the monitoring programme.
An on-site facility inspection will then be scheduled once the regular inspection programme resumes.
Amendments and deviations
It is important that compliance with the principles of GLP continues to be maintained.
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.
Quality Assurance (QA)
Maintaining an adequate QA programme is essential and it is recommended that QA activities are prioritised using a risk based approach. A risk assessment can be used to identify where to focus resource and adapt audit programmes.
If planned QA audits cannot be conducted or are delayed due to lack of available resource or travel restrictions, the impact this has on the study should be assessed and documented by the study director.
The use of remote technology such as video calls as an alternative to physical presence would be considered acceptable provided there is enough detail within study records to reconstruct activities and that the method of observation can be identified. The use of remote observation methods should be fully risk-assessed to ensure they provide a similar level of oversight as a physical audit.
We recommend you consult the MHRA guidance for GLP facilities on implementing and maintaining a risk-based quality assurance programme, which provides information on possible approaches for QA programmes.
Communication of significant issues
The GLPMA should be informed, via email, of any significant changes that happen with regard to the premises, activities or management of a Test Facility to firstname.lastname@example.org.