Last May, EMA opened a brief, one-month public consultation procedure (13 May 2022 – 13 June 2022), 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“.
The COVID-19 pandemic has affected standard way of working, requiring the need to work remotely to ensure operations under business continuity mode.
To minimise risks of shortages while ensuring that the high standards of quality, safety and efficacy of medicines made available to patients in the EU were maintained, EMA has therefore developed, in cooperation between the European Commission and the Coordination Group for Mutual Recognition and Decentralised Procedures – Human Medicine (“CMDh”), guidance on adapting “regulatory expectations” as a result of the new context created.
This guidance contemplates the possibility 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 evaluating 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 on an emergency basis.
The draft Q&A document, published on May 11, discusses the appropriate requirements and conditions for allowing QP work remotely.
The text clarifies that since 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.
Proceeding from the requirements in Annex 16 regarding validation and certification activities carried out by the QP, the text outlines four clarifications, expressed in question-and-answer form:
1. Is remote batch certification/ batch confirmation by the QP allowed on a routine basis?
2. Where remote QP certification / confirmation is allowed on a routine basis, what conditions should apply?
3. Is the QP required to be a resident in the Member State where the authorised site is located?
4. What are the technical requirements for the remote access and the signature used for batch certification / confirmation?
Commissione Europea, EMA ed HMAs – Q&A on regulatory expectations for medicinal products for human use during the COVID-19 pandemic
