AEMPS slams QC systems at Euro Far Alergi plant

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Quality control, Quality assurance, Immune system

Spanish regulators have criticised operations at a facility operated by vaccine firm Euro Far Alergi S.L.

The Spanish Agency of Medicines and Medical Devices (AEMPS) detailed its concerns in a post on EudraGMDP​, explaining that quality control measures are not sufficient to assure the quality of manufactured and released products.

The agency also said raised concerns that processes used to inactivate the bacterial vaccines and autovaccines at the site are not validated

AEMPS withdrew Euro Far Alergi’s manufacturing and importation authorisation (MIA) and good manufacturing practices (GMP) certificate and banned it from shipping any more products.

Related topics: Markets & Regulations, Regulations, QA/QC

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