EMA tackles the Issue of Remote Batch Certification

Recommendation

26-28 April 2023
Hamburg, Germany

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EMA today opened a short, one-month public consultation on a draft question and answer document on remote certification of batches by the Qualified Person (QP): "Public Consultation concerning the physical Attendance and the Location of Personal Residency of The Qualified Person" (EMA/INS/169000/2022).

The COVID-19 pandemic also had some impact on the way companies work. The place of batch certification by the QP was and is also affected by this. Many QPs remained in their home offices partly or even all of the time during the pandemic. For the various changed conditions and procedures during the pandemic, EMA has developed guidance in cooperation between the European Commission and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human Medicine ("CMDh"). Comparable guidance also exists for veterinary medicines. This guidance recognises that the work of QPs needs to be adapted to allow remote batch certification when on-site presence is not possible. The GMDP inspectors' working group is currently considering the possible flexibility for the physical presence of the QP at the authorised manufacturing site when batch certification or confirmation is carried out routinely and not only in emergencies.

The draft Q&A document now published discusses appropriate requirements and conditions. However, the ultimate responsibility for the interpretation of EU legislation lies with the European Court of Justice. The content of this document is therefore subject to any other interpretation by the European Court of Justice.

The document has been published for comment with a deadline of just four weeks, which underlines the urgency of these issues.

Questions to be resolved here are:

• Is remote batch certification/ batch confirmation by the QP allowed on a routine basis?
• What conditions should apply?
• Is the QP required to be a resident in the Member State where the authorised site is located?
• What are the technical requirements for the remote access and the signature?