Regulatory Focus™ > News Articles > Spanish Regulator Cites Madrid Drugmaker for Manufacturing Violations

Spanish Regulator Cites Madrid Drugmaker for Manufacturing Violations

Posted 20 December 2016 | By Michael Mezher 

Spanish Regulator Cites Madrid Drugmaker for Manufacturing Violations

The Spanish Agency of Medicines and Medical Devices (AEMPS) has issued a statement of non-compliance to Madrid, Spain-based drugmaker Angulema, S.L., and ordered the recall of more than 400 lots of the company's vaccines.

According to AEMPS, "the quality of the products manufactured by this site cannot be assured," after a two-day inspection uncovered "critical and major deficiencies" impacting Angulema's quality system and manufacturing processes for the company's products, which include subcutaneous, sublingual and nasal formulations of bacterial vaccines, bacterial auto-vaccines, and allergenic vaccines.

Specifically, AEMPS says the Angulema lacks an effective pharmaceutical quality system and released "batches of bacterial vaccines and bacterial auto-vaccines … without performing the sterility tests according to [the European Pharmacopoeia] Eu. Ph."

AEMPS also says the company did not perform a series of other processes required under good manufacturing practice (GMP) requirements, including process validation and media fill process simulation for aseptic processes.

Additionally, AEMPS says the company failed to perform validation activities for ensuring its bacterial vaccines and bacterial auto-vaccines are sterile and inactive.

Statement of Non-Compliance, Recall


Tags: AEMPS, Angulema

Categories: Regulatory News

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