The UK Medicines and Healthcare products Regulatory Agency has introduced good manufacturing practice (GMP) flexibilities for qualified persons (QPs) at companies who are dealing with medicines imported from third countries during the coronavirus (COVID-19) outbreak.
In a newly published guidance, the MHRA explains, for example, how Annex 16 of the EU GMP guidelines on certification by a QP and batch release provides a mechanism to allow certain “unexpected deviations” in analytical control methods or manufacturing processes.
“We believe there is scope for QPs to apply the same principles to minor deviations in the finished product specifications where, in their professional judgement, safety and efficacy is not compromised,” the agency says.
The new guidance also discusses how the agency is using a mechanism in Annex 16 to introduce flexibilities for QPs with regard to relying on information from third parties (eg, audits) to confirm the correct functioning of the pharmaceutical quality system of sites involved in the manufacture of the product.
“We consider that adhering to the principles for third party reliance set out in Annex 16 – in the current exceptional circumstances – could give QPs some flexibility by not having to repeat all quality control tests on importation from a third country manufacturer,” the agency says.
The guidance says that re-testing on importation should continue whenever possible, and it explains what flexibilities the MHRA has introduced on this front. Where flexibility has been used to omit re-testing on importation, “a risk-based, retrospective skip lot approach for full re-testing of imported batches should be undertaken to inform the QP of continued quality,” it declares.
In addition, it provides advice on sharing information with the supply chain to help ensure a high level of trust that each link in the supply chain is complying with the accepted standards. It says that where information is shared with others in the supply chain, it should be reported to the Covid19.GMDP@mhra.gov.uk mailbox.
The guidance also deals with medicines being marketed outside the UK. Here it says that if the medicine might also be marketed outside the UK, and/or if the QP is operating under a manufacturing authorization granted by another European Economic Area medicines competent authority, the report must also be sent to the competent authority of the relevant market. “We must be informed if that competent authority has any objections.”
The MHRA also urges QPs to let it know as soon as possible if they are finding that Annex 16 is not providing enough flexibility to deal with the current logistical challenges quickly.
“Reporting any difficulties will help us to monitor the national situation in real time, ensuring we can take actions that support supply chains and address common difficulties as situations change,” it says.
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