COVID-19: How to manage temporary GDP Process Changes and Risks

Recommendation

14/15 December 2021

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In its Inspectorate Blog the Medicines and Healthcare products Regulatory Agency (MHRA) has recently published a post on temporary changes in Good Distribution Practice (GDP) entitled "How to manage temporary GDP process changes and risks through the COVID-19 pandemic".

A few weeks ago, the MHRA published a Guidance on "Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak". The guidance contains a list of temporary regulatory flexibilities that will be allowed to address the current exceptional circumstances.

In addition, the post published in the MHRA Inspectorate Blog points out once again that during the Covid-19 pandemic, it might be necessary to adjust how companies operate, e.g. using temporary process deviations and temporary staff. "Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles as described in the EU Guidelines on Good Distribution Practice for finished products. [...] The ultimate aim should be to ensure the medicines provided to patients remain safe and effective and the integrity of the supply chain is maintained."

Companies encountering significant operational challenges that may require additional regulatory flexibilities should contact the MHRA GDP inspectorate via email at GDP.Inspectorate@mhra.gov.uk.