European Medicines Agency (EMA) has published new questions and answers on remote batch certification / confirmation by the Qualified Person (QP) .The topic applies to EU/EEA QP certification or QP confirmation, as described in EU GMP, and specifically in EU GMP Annex 16. It is applicable to the manufacture and importation of human and veterinary medicinal products as well as investigational medicinal products.
EMA states that the decision on the remote batch certification / confirmation by the qualified person (QP) is left to the national competent authorities of the Member States where the authorised site is located. Manufacturer should consult national competent authorities to determine any additional requirements. Currently there are no harmonized requirements concerning the residency of QPs in the EU legislation.
When remote QP certification / confirmation is allowed by the national competent authority, the following points should apply:
- it should be carried out in full accordance with EU legislation and EU GMP guidelines,
- it should take place within the EU/EEA (or Northern Ireland) in all cases,
- QPs are obliged to maintain their knowledge in relation to the products, manufacturing processes and pharmaceutical quality system,
- QPs ongoing reliance on the relevant pharmaceutical quality system should be well founded,
- the QP must be able to demonstrate knowledge of the product and the manufacturing processes for which they are responsible (this should include time spent physically on-site as applicable),
- remote QP certification / confirmation must be described and controlled within the pharmaceutical quality system and relevant detailed site procedures should be in place,
- the technical agreement between the MIA holder and the contract QP should also mention remote certification / confirmation, and specify the circumstances under which the QP must attend the site,
- the QP should have access to all information (data and computer system applications) which are necessary according to Annex 16 to make an informed decision on batch certification / confirmation,
- the MIA holder should provide the required facilities to enable QPs to carry out their functions remotely including equipment and IT support,
- all actions should be contemporaneously available for inspection by the competent authorities and self-inspection,
- only the QP has editing access to the batch certification function,
- all data being transferred are complete and unchanged,
- electronic signature, in accordance with requirements in Annex 11, is in place.
Compliance with the above points should be verified and all IT systems used for remote batch release should comply with requirements of EU GMP Annex 11.