Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19)

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines operational adjustments for Good Laboratory Practice (GLP) facilities during the COVID-19 pandemic. The agency transitioned to office-based inspections to ensure continued membership in the monitoring program, with on-site visits to follow once normal operations resume. Organizations are expected to maintain strict adherence to GLP principles throughout this period. Any disruptions caused by the pandemic that might affect a study's regulatory status must be thoroughly evaluated, managed, and documented through standard amendment and deviation processes. Facilities should prioritize Quality Assurance (QA) activities using a risk-based approach. If travel restrictions or resource shortages delay audits, the Study Director is responsible for assessing and documenting the potential impact on study integrity. The MHRA supports the use of remote technology, such as video conferencing, as an alternative to physical presence, provided these methods are risk-assessed and allow for the full reconstruction of activities within study records. Required actions for facilities include maintaining detailed documentation for all deviations, performing robust risk assessments for remote auditing procedures, and notifying the GLPMA of any significant changes to premises or management via email to ensure ongoing compliance.