Tag Archive: calibration

  1. MHRA Maintenance and Calibration: COVID-19

    Comments Off on MHRA Maintenance and Calibration: COVID-19

    MHRA publish GxP flexibilities for maintenance and calibration during COVID-19 outbreak

    The MHRA has published guidance in regards to allowing some alternative courses of action for manufacturing or laboratory equipment maintenance and calibration during the COVID-19 outbreak. 

    This includes clear guidance on measures to take:

    • If an engineer is available to attend site
    • If an engineer cannot attend site but is available by either telephone or video call
    • If an engineer is not available to attend site and remote supervision is not possible
    • Off-site calibration/maintenance
    • Substitution of laboratory equipment

    How can Biomap help?

    Biomap engineers remain available to attend sites where calibration is required. We have added additional Health & Safety Risk Assessments for every site visit, which includes considerations of social distancing and PPE to reduce potential exposure to all personnel where possible.

    For clients wishing to avoid engineer visits, we can offer tailored plans to calibrate equipment back at the Biomap facility (where possible) or provide support with Risk Assessments for postponements. Also, we can provide calibrated hardware to cover areas monitored by expiring equipment.

    Contact us for further information – info@biomap.co.uk

    See full MHRA release:  

    Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak – https://bit.ly/2WN1u5v 

  2. MHRA Qualification & Validation: COVID-19

    Comments Off on MHRA Qualification & Validation: COVID-19

    MHRA publishes GDP flexibilities for Qualification & Validation work during COVID-19 outbreak

    The MHRA has published guidance concerning some flexibilities in Good Distribution Practice during the COVID-19 pandemic. This includes some exceptional allowances within the supply chain, transportation, and storage. One particular area is regarding the benefit of retrospective Qualification and Validation work but must be carefully recorded and supported by a risk assessment. 

    “Storage and distribution equipment may be used with limited qualification and validation to allow equipment to be used as soon as possible. This should be supported by a risk assessment and additional mitigating measures where necessary. Remaining qualification and validation work should be completed retrospectively, with delay minimised as much as possible”

    How can Biomap help?

    Biomap can support the Risk Assessment process if projects need to be postponed, and retrospective validation will be carried out later on due to the pandemic. We can assist with collating the required information and presenting it in the correct formats. For example:

    • Assessment of equipment/facility being validated
    • Review of Change Control
    • Validation due dates & required works
    • Historical works and performance
    • Summary of actions
    • Drafting Risk Assessment

    Alternatively, Biomap can also offer a range of remote qualification kits for clients to continue to execute their validation schedules as planned (without the need of an engineer on site)  https://biomap.co.uk/covid19-remote-validation-service/  

    Contact us for further information – info@biomap.co.uk

    See full MHRA release: “Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak”: https://bit.ly/2YBuNch