Spanish Regulator Suspends Vaccine Company for Quality Violations

Posted 06 February 2017 By Michael Mezher

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The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) has withdrawn Spanish drugmaker Euro Far Alergi's good manufacturing practice (GMP) certificate over quality issues uncovered during a three-day inspection of the company's Madrid, Spain facility in January.

AEMPS has also temporarily suspended the company's manufacturing and importation authorization and ordered a recall of vaccines produced at the site.

According to AEMPS, the affected products include aseptically prepared autovaccines, bacterial and allergenic extract vaccines, and sublingual, oral and nasal bacterial vaccines, and have only been distributed within Spain.

Quality Issues

In its statement of non-compliance, AEMPS says it identified issues with Euro Far Alergi's quality control activities that cast doubts on the company's quality system.

"Quality control activities in general do not assure an appropriate, reproducible and requested quality of manufactured and released products since raw materials and conditioning materials are not controlled at reception neither according to GMP nor to EU. Ph. [European Pharmacopoeia]," AEMPS writes.

AEMPS also says the company did not properly validate its processes for ensuring the sterility of finished products.

"Media fill tests do not demonstrate that the process is performed in aseptic conditions, and the environmental monitoring, [the] facility's cleaning and disinfection, and … hygiene of gowning are not in compliance with [EudraLex – Volume 4] Annex 1 for manufacture of sterile products."

Additionally, AEMPS says the company's processes for inactivating bacterial vaccines and autovaccines have not been properly validated.

EudraGMP

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