Exceptional GMP flexibilities for medicines imported from third countries during the coronavirus (COVID-19) outbreak
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
We have also published guidance on Exceptional good distribution practice (GDP) flexibilities for medicines during the outbreak
Unexpected deviations
Annex 16 of GMP 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.
Relying on information from third parties
Annex 16 also refers to the ability of QPs to rely on information from third parties (e.g. 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.
Re-testing on importation should continue whenever possible. Where the QP concludes that completion of certain re-testing prior to batch certification of imported products will itself lead to delays and supply chain shortage, flexibilities might involve, for example:
- not carrying out product re-testing on importation if the batch has been fully tested in a PIC/S country
- only performing identity and assay for products if manufactured in a non-PIC/S territory, if fully tested to equivalent standards by the third country manufacturer.
Re-testing on importation
Where this flexibility is 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. Quality attributes that have failed import re-testing should continue to be tested for all imported batches until robust preventative actions have been implemented and confirmed by the QP. For biological products, specialist analyses (e.g. vaccine inactivation tests) should continue to be performed on importation.
Again, this would be where, in the QP’s professional judgement, safety and efficacy is not compromised and where the purpose of the action is to maintain supply in the interest of public health. In addition, the laboratory of the third country manufacturer would have been inspected by an EU inspectorate or mutual recognition partner and granted GMP approval for this work.
If professional judgement is used to permit the deviations above, in particular dispensing with re-testing on import, this decision should be recorded as normal in the pharmaceutical quality system and reported to the [email protected] mailbox. Please include in the subject line of the email ‘GMP flexibilities’.
Sharing information with the supply chain
The QP must also consider, as we will consider, telling others further down the supply chain. This will help to ensure a high level of trust that each link in the supply chain is complying with the accepted standards.
Where information is shared with others in the supply chain, it should be reported to the [email protected] mailbox. Transparency is the key to this being implemented safely.
Read more about reporting use of flexibilities.
Medicines being marketed outside the UK
If the medicine might also be marketed outside the UK, and/or if the Qualified Person is operating under a manufacturing authorisation granted by another EEA 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.
Reporting any difficulties to us
If QPs are finding that Annex 16 is not providing enough flexibility to deal with the current logistical challenges quickly, please report this to us as soon as possible.
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.
We rely upon any difficulties being reported to us quickly, so we take steps to adjust the regulatory system. This will ensure we can meet the needs of the system and fully support critical supply chains, whilst continuing to protect public health.