Laboratorio Angulema warned by Spanish regulators about Leganes plant

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Medicine

Spanish regulators have found problems at a facility operated by immunotherapy producer Laboratorio Angulema.

AEMPS (Spanish Agency of Medicines and Medical Devices) detailed its concerns in a EudraGMDP filing​ published today.

Inspectors identified deficiencies in manufacturing quality systems during an inspection of the site in Leganes near Madrid, Spain in November.

The agency said: “Critical and mayor deficiencies detected on the last inspection carried out on 16-17/11/16 impact on the quality system of the site and the manufacturing process of inmunological medicinal products​.”

Critical deficiencies included the “lack of an effective pharmaceutical quality system​” and the fact the firm released batches of bacterial vaccines without performing sterility checks or process validation.

AEMPS also said: “Validation of inactivation process for bacterial vaccines and bacterial auto-vaccines is not performed. Thus, the quality of the products manufactured by this site cannot be assured​.”

Laboratorio Angulema makes subcutaneous sterile bacterial vaccines, subcutaneous sterile bacterial auto-vaccines and subcutaneous sterile allergenic vaccines, primarily for the Spanish market.

AEMPS temporarily suspended the firm’s manufacturing and importation authorisations (MIA).

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

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