The EDQM quickly established a business continuity plan to anticipate and mitigate any risks of disruption to its activities caused by the COVID-19 pandemic, so that the standards necessary for the production and release of medicines by pharmaceutical manufacturers and for market surveillance testing by Official Medicines Control Laboratories (OMCLs) remain available. Specific measures have also been taken to ensure the granting and revision of certificates of suitability (CEPs).

To protect the health of staff and the public, most EDQM staff not essential to conducting experimental or physical operations on-site have been working remotely to varying degrees and in compliance with lock-down and public health measures in force in France, the EDQM’s host country. The tools and measures implemented during the initial lock-down in the spring of 2020 proved to be effective and efficient and the EDQM therefore remains able to provide its services even under circumstances which continue to be difficult. The EDQM is closely monitoring the situation and will continue to adapt its working methods to comply with the health measures taken by the host country and with strict health and safety regulations.

All EDQM operations are running and business continuity measures are being continually monitored and adapted, as necessary.

Pharmacopoeia and quality standards

The work of the European Pharmacopoeia Commission and its 61 groups of experts and working parties is progressing regularly. Meeting schedules and publication deadlines have been respected, thanks to efforts and adjustments made by all those involved. The European Pharmacopoeia Supplement 10.8 is now available to Ph. Eur. users.

The European Pharmacopoeia Online and its public consultation platform Pharmeuropa, as well as all other databases and documentary resources, are functioning normally, are fully accessible and are continually updated.

Likewise, the European Pharmacopoeia Archives, available to all users with an up-to-date subscription (print or electronic), have been updated with the three volumes of the 10th Edition (10.0).

 

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Reference standards

The EDQM continues to ensure the supply of its reference standards to help maintain the availability of quality medicines in Europe and beyond. Due to the pandemic, the functioning of the EDQM laboratory, manufacturing and logistics entities has been adapted and reinforced to protect the health, safety and security of staff while they continue to develop, produce and dispatch reference standards.

  • Ensuring the availability of quality standards for medicines in the context of the COVID-19 pandemic

To continue responding to evolving public health needs, the EDQM constantly monitors substances used in intensive care units to treat COVID-19 symptoms and in clinical trials specifically related to this disease.

Even if the situation regarding the supply chain has improved since the start of the pandemic, shipping is still difficult in some countries. The EDQM systematically strives to find the best shipment options, but delays may still occur for some destinations.

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Certification of suitability to the monographs of the Ph. Eur.

Applications for certificates of suitability (CEPs) continue to be received and are assessed in accordance with the CEP procedure. The EDQM informs applicants electronically of the outcome of the evaluation. CEPs are sent out electronically in a secure manner and paper documents continue to be shipped by carrier.

Lockdowns throughout Europe and the world have affected processing times for the evaluation of CEP dossiers (new dossiers and revisions). The actual timelines are reported regularly in the CEP monthly reports published on the EDQM website. To mitigate the impact of the absence of assessors from national competent authorities at the EDQM, alternative solutions have been developed. Remote evaluations are organised by the Certification Department to increase the number of dossiers treated monthly.

All on-site inspections have been postponed until further notice due to current travel restrictions around the globe. The EDQM is monitoring Good Manufacturing Practice (GMP) compliance of sites through exchanges of information with international partners and distant assessments. In addition, the EDQM has developed an alternative inspection mode. A corresponding project, entitled “Real-Time Remote Inspections” (or RTEMIS for short) has been initiated and so far nine companies in Asia (eight in India and one in China) have been invited to take part. This pilot project combines a live video feed, linking inspectors and manufacturing sites of active pharmaceutical ingredients (APIs), and the review of documentary sources, with the objective of monitoring compliance with both GMP and applications for CEPs in manufacturing sites. The initial results are promising. More details are available on the EDQM web site: EDQM “RTEMIS” pilot project.

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OMCL Network: quality control of medicines, including Official Control Authority Batch Release procedure

In the interest of public health, the EDQM is closely collaborating with the OMCLs involved in the testing of human and veterinary medicines to help ensure continuity of important activities, including the Official Control Authority Batch Release (OCABR) of vaccines and human blood- and plasma-derived medicinal products. Release of non-COVID-19-related products has continued at normal levels thanks to careful contingency planning at the OMCLs.

To organise the transfer of the batch release tests for COVID-19 vaccine candidates to OMCLs earlier than in the usual process, the EU OCABR Advisory Group prepared a recommendation document on method transfer for OMCLs and manufacturers. The OCABR network members also prepared a list of OMCLs with capabilities relevant to the release of COVID-19 candidate vaccines to help manufacturers identify potential partners for the OCABR of their candidate vaccines which is updated regularly to adapt to the existing conditions. Interested manufacturers can request a copy of either document via batchrelease@edqm.eu.

OCABR guidelines for pandemic COVID-19 vaccines were prepared at an early stage in order to help anticipate the launch of the first vaccines and allow OMCLs and manufacturers to take the necessary steps to prepare for OCABR, thus preventing delays in availability while still ensuring their quality and safety.

Thanks to this activity and the action and co-operation of regulators and manufacturers, batches of all of the COVID-19 vaccines with conditional marketing authorisation (cMA) approval in the EU were released and ready to reach patients as soon as the cMA approval was granted.

The EDQM continues to work with all stakeholders to protect public health by ensuring the necessary quality, safety and security checks for COVID-19 candidate vaccines are maintained, and by promoting access to vaccines.

Access to the guidelines can be found on the web page: "OCABR activities related to COVID-19 vaccines".

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