Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak

The document outlines options for manufacturers and GxP laboratories during the COVID-19 pandemic, when service personnel or external engineering support may not be able to operate as normal. Options include remote supervision by phone or video call, electronic approval and documentation, and off-site calibration/maintenance for manoeuvrable equipment. In cases where remote supervision is not possible, a quality system record should be raised and the delay to calibration or maintenance tasks risk assessed, considering criticality, frequency, and performance checks. The goal is to maintain compliance status and perform tasks at the earliest opportunity when restrictions are lifted.