The European Medicines Agency EMA has published new questions and answers on remote batch certification/ confirmation by the Qualified Person (QP). These questions and answers apply to EU/EEA QP certification or QP confirmation, as described in EU-GMP, and specifically in Annex 16. It is applicable to the manufacture and importation of human and veterinary medicinal products as well as investigational medicinal products. However, there are no clear statements or even regulations given, but rather the decision is left to the national competent authorities.
It is stated that "Remote batch certification/ batch confirmation could be allowed if accepted by the national competent authority where the authorised site is located. Some competent authorities may have specific requirements regarding the implementation of remote batch certification/ batch confirmation on a routine basis. Manufacturers and QPs should ensure that they comply with any applicable local requirements. In order to determine what requirements apply, manufacturers should consult with their national competent authority."
However when accepted by the national competent authority, expectations are defined and the following points should be taken into consideration:
QP certification/confirmation is carried out in full accordance with EU legislation and EU GMP guidelines
QP certification/ confirmation 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
Ongoing reliance on the relevant pharmaceutical quality system is well founded
The QP must be able to demonstrate knowledge of the product and the manufacturing processes
Remote QP certification/ confirmation must be described and controlled within the pharmaceutical quality system
The technical agreement between the MIA holder and a 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 a decision
The MIA holder should provide the required facilities to enable QPs to carry out their functions remotely including equipment
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
Data being transferred are complete and unchanged
An electronic signature, reflecting requirements in Annex 11, is in place