# Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a57f8dd3-4b7b-4723-af26-ce08b0f0f5aa Type: Detailed Guide Published: April 7, 2020 > 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. --- ## Content During the coronavirus pandemic it may not be possible for service personnel or external engineering support to operate as normal. The following options are available to manufacturers and GxP laboratories. If an engineer is available to attend site A risk assessment should be performed to assess COVID-19 transmission risks in line with government advice. Company health and safety procedures should be deployed so the engineer can ensure social distancing and be supervised adequately during their time on site. Calibration and maintenance protocols may be reviewed prior to the engineer visiting the site as per routine requirements. However, approval may be given electronically. Site visit documentation may also be signed electronically. If an engineer cannot attend site but is available by either telephone or video call A suitably trained employee may perform the calibration or maintenance task under the remote supervision from the engineer providing the site has all the required materials, parts and tools to perform the task. The risks of this should be assessed and if required, the next maintenance or calibration task brought forward once current restrictions are lifted. If an engineer is not available to attend site and remote supervision is not possible A quality system record (e.g. change control or deviation) should be raised and the delay to the calibration or maintenance task should be risk assessed, considering; the criticality of the equipment and its intended use frequency of the calibration/maintenance whether it is an interim or annual recalibration/maintenance task prior performance, including ‘drift’ between previous calibration or maintenance visits and recent breakdown history performance checks that are performed on the equipment prior to use if alternative equipment is available to perform the task and is within its calibration/maintenance period The risk assessment should also consider additional performance checks and verifications that should be performed to monitor the compliance status of the equipment. The delay to a calibration or maintenance task should be documented and managed by the quality management system. The documentation should be transparent to allow the person responsible for releasing product or making a regulatory claim of compliance to make a full and accurate assessment. The calibration or maintenance task should be performed at the earliest opportunity when current restrictions on movement are removed. Equipment taken out of service following risk assessment should have outstanding maintenance or calibration work completed prior to being put back into use. Off-site calibration/maintenance There may be an option for manoeuvrable equipment to be shipped off-site for calibration or maintenance to be performed. If this is not standard practice then the change should be assessed, detailing the risks of equipment leaving the site and the impact on the calibration or maintenance once the equipment has been returned and an assessment made as to whether it is fit for the intended use. Substitution of laboratory equipment Any analytical methods that may have been validated on a specific make/model of equipment may be transferred to an equivalent instrument after assessment of the impact on the validation status of the method. If required, method validation may need to be performed to ensure the validity of the results generated. MHRA guidance on coronavirus (COVID-19) .