EMA: Q&A on Remote Batch Certification and QP Residency
The European Medicines Agency (EMA) has published four new questions and answers around Remote Batch Certification/Confirmation of a Qualified Person (QP). One Q&A deals with the residence specification for a QP. They apply to EU/EEA QP certification or QP confirmation, as described in EU GMP, and specifically in Annex 16. It applies to the manufacture and importation of human and veterinary medicinal products and investigational medicinal products.
As EMA explains in Q&A 1, remote batch certification may be allowed if accepted by the national regulatory 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.
Q&A 2 describes the requirements that have to be fulfilled if remote certification is granted, such as:
- QP certification/confirmation should take place within the EU/EEA (or Northern Ireland) in all cases. This should be demonstrated by technical means.
- QPs are obliged to maintain their knowledge in relation to the products, manufacturing processes, and pharmaceutical quality systems. QPs must also be satisfied that their ongoing reliance on the relevant pharmaceutical quality system is well-founded. The QP must be able to demonstrate to the competent authority knowledge of the product and the manufacturing processes for which they are responsible. This should include time spent physically on-site as applicable.
- Where remote QP certification/confirmation is employed on a routine basis, it must be described and controlled within the pharmaceutical quality system and relevant detailed site procedures should be in place. In Member States where the use of contract QPs (i.e. a person who is not an employee of the manufacturer but conducting QP activities under the manufacturer’s authorisation) is permitted, the technical agreement between the MIA holder and the 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) that are necessary according to Annex 16 to make a decision on batch certification/confirmation.
- The MIA holder should provide the required facilities to enable QPs to carry out their functions remotely. This includes the equipment and support required to enable electronic batch certification/confirmation and completion of the batch certification register remotely. IT systems used for remote batch release should comply with the requirements of EU GMP Annex 11.
Consideration should also be given to ensuring that the technical requirements for remote certification regarding IT security and data integrity are met. Details on this are listed in Q&A 3.
EMA explains in Q&A 4 that EU legislation does not currently impose harmonised requirements on the place of residence of qualified persons. However, it is noted that different national requirements may apply in some Member States.
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