EDQM Publishes Guidelines on Batch Release for COVID-19 Vaccines

The European Directorate for the Quality of Medicines & HealthCare (EDQM) announced on Nov. 12, 2020 three new Official Control Authority Batch Release (OCABR) guidelines that describe the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the European Union (EU) OCABR Network. The guidelines are part of the independent control of pandemic COVID-19 vaccine batches.

The guidelines address vaccines expected to enter the European market first, with additional guidelines to come that will address other COVID-19 vaccine types under development. The new guidelines, which were prepared using current knowledge, are Pandemic COVID-19 Vaccine (Non-Replicating Chimpanzee Adenovirus-Vectored Vaccine); Pandemic COVID-19 Vaccine (Non-Replicating Human Adenovirus-Vectored Vaccine); and Pandemic COVID-19 Vaccine (mRNA Vaccine). According to EDQM, the guidelines will be reviewed and updated as necessary once relevant market authorizations have been approved.

“As part of OCABR, OMCLs will perform the prescribed tests and make a careful review of the batch release protocol from the manufacturer. The protocol will include data on all the quality control tests for batch release performed by the manufacturer, as approved in the marketing authorization. Only batches that are compliant with the approved quality standards will be released. Independent control of each batch of COVID-19 vaccine, before it reaches the patient, is an important part of the EU regulatory network strategy to ensure the availability of vaccines that meet the appropriate quality requirements and to protect public health. COVID-19 vaccines are eligible for EU OCABR according to Article 114 of EU Directive 2001/83/EC, as amended,” EDQM stated in a press release.