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

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued this guidance to assist manufacturers and GxP laboratories in managing equipment calibration and maintenance during the COVID-19 pandemic. Because pandemic restrictions may prevent external engineers from accessing sites, the document outlines several flexible options to maintain compliance with Good Practice (GxP) standards. When an engineer can visit, companies must conduct risk assessments for virus transmission and may utilize electronic signatures for documentation. If on-site visits are impossible, the MHRA allows for remote supervision, where trained internal staff perform tasks under an engineer's guidance via video or telephone. In scenarios where maintenance must be delayed, the guidance requires the incident to be recorded in the quality management system as a change control or deviation. These delays must be supported by a comprehensive risk assessment evaluating the equipment's criticality, historical drift, and the availability of alternative instruments. Additional actions include the possibility of shipping equipment off-site or substituting validated instruments with equivalents, provided the impact on method validation is reviewed. All delayed tasks must be completed at the earliest opportunity once movement restrictions are lifted. This framework ensures that equipment integrity is documented transparently, allowing responsible personnel to make informed decisions regarding product release and regulatory compliance despite the disruptions caused by the pandemic.