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/

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