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

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a1fa2e4a-9c2d-41e8-ac61-df1b4d8c6685
Type: Detailed Guide
Published: March 30, 2020
Updated: August 11, 2020

> 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.

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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 gxplabs@mhra.gov.uk . MHRA guidance on coronavirus (COVID-19) .