The EDQM has established a business continuity plan to anticipate and mitigate any risks of disruption to its activities, 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 during the COVID-19 pandemic. 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 are working remotely during the current lock-down in France, the EDQM’s host country. The tools and measures implemented during the spring lock-down proved to be effective and efficient and the EDQM therefore remains able to provide its services even under these difficult circumstances. The EDQM is closely monitoring the situation and will continue to adapt its working methods to comply with the host country’s lock-down measures and 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
- Reference standards
- Certification of suitability to the monographs of the European Pharmacopoeia
- OMCL Network: quality control of medicines, including Official Control Authority Batch Release procedure
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. Recent highlights include:
- the publication of European Pharmacopoeia Supplement 10.4, which is now available to Ph. Eur. users;
- the publication of 42 draft texts for public consultation in Pharmeuropa 32.4, allowing users to comments until 31 December 2020.
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).
The EDQM is ensuring 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 has compiled a list of substances used in intensive care units to treat COVID-19 symptoms and in clinical trials specifically related to this disease. The supply chain for these substances will be constantly monitored to avoid any disruption.
More information available here.
Applications for new, revised or renewed certificates of suitability (CEPs) continue to be received and are assessed in accordance with the 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. However, some delays in reception of documents may still be encountered due to transport disruptions currently affecting some carriers and certain regions.
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 GMP compliance of sites through exchanges of information with international partners and distant assessments. In addition, the EDQM is studying the possibility of conducting real-time remote inspections. A corresponding project (RTEMIS) has been initiated and two companies in India have been invited to take part in a pilot phase. The initial results are promising.
The EDQM is aware that companies may have issues regarding submissions of information linked to CEP dossiers under assessment (e.g. preparing and sending responses to deficiency letters) and inspections (e.g. preparing and sending CAPA). The EDQM expects to be informed as soon as possible by CEP holders/substance manufacturers in case they cannot meet deadlines for submitting the information requested.
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, where, as a mitigating measure, the EU OCABR network has adopted an emergency strategy, in force since 31 March 2020, to assure the continued release of these essential medicines.
In order to organise the transfer of the potential future batch release tests for COVID-19 vaccine candidates to OMCLs earlier than in the usual process, the EU OCABR Advisory Group has prepared a recommendation document on method transfer for OMCLs and manufacturers. The OCABR network members have also prepared a list of OMCLs with capabilities relevant to the future release of COVID-19 candidate vaccines to help manufacturers identify potential partners for the OCABR of their candidate vaccines. Interested manufacturers can request a copy of either document via email@example.com.
OCABR guidelines for pandemic COVID-19 vaccines have been 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.
Access to the guidelines can be found here.