Corona: UK expands QP Discretion

Annex 16 of the EU-GMP Guidelines (which is still valid in the UK) states that a "QP may consider confirming compliance or certifying a batch where an unexpected deviation concerning the manufacturing process and/or the analytical control methods from details contained within the MA [Marketing Authorisation] and/or GMP has occurred". However this will only be possible if "registered specifications for active substances, excipients, packaging materials and medicinal products are met".

Now the U.K. Medicines and Healthcare Products Regulatory Agency MHRA has published Guidance for "Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak". Qualified Persons (QPs) should follow this guidance now for medicines imported from third countries.

In the current exceptional circumstances a U.K. QP might now have some flexibility with the following decisions:

  • QP Discretion for minor deviations even in finished product specifications when, in the QP's professional judgement, "safety and efficacy is not compromised".
  • Omission of quality control tests on importation.

This additional flexibility might sound reasonable but it will put a lot of additional responsibility on the QPs. Transparency and information sharing will be very important. The MHRA asks the QP to pass all relevant information further down the supply chain "to ensure a high level of trust". Where information is shared with others in the supply chain, it should also be reported to the mailbox.

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