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, QA/QC, Regulations

Related news

Related products

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Related suppliers

Follow us


View more