The COVID-19 pandemic required manufacturers and importers of medicinal products and regulatory authorities to operate under business continuity mode, impacting the standard way of working. As a result, document has been developed in 2021 in cooperation between the European Commission and EMA containing guidance on regulatory expectations and flexibility during the COVID-19 pandemic 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. This guidance published by the European Commission is available here (for medicines for human use) and here (for medicines for veterinary use).
The guidance recognised that the work of the Qualified Person (QP) required adaptation, permitting remote batch certification when on site presence was not possible. The EMA GMP/GDP Inspectors Working Group is currently reviewing the flexibilities concerning requirements for the QP’s physical attendance at the authorised manufacturing site when performing batch certification or batch confirmation on a routine basis, outside of an emergency situation. A set of Question and Answers has been drafted reflecting on the conditions which should apply and the appropriate technical requirements to facilitate remote certification and confirmation (Public consultation concerning the physical attendance and the location of personal residency of the qualified person, EMA/INS/169000/2022).
The purpose of this consultation is to collect relevant information from stakeholders to help the GMP/GDP Inspectors Working Group to finalise this Question and Answers guidance on remote batch certification / confirmation by the QP on a routine basis. Comments on the proposed text should be submitted no later than 13 June 2022 by email to ADM-GMDP@ema.europa.eu.