The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

AEMPS Suspends Spanish Manufacturer’s License

Jan. 27, 2017
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Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies.

The critical and major deficiencies observed in a November inspection concern the quality system and manufacturing process for immunological medicines — such as the company’s subcutaneous sterile bacterial and allergenic vaccines, the AEMPS said.

Namely, the company failed to implement an effective pharmaceutical quality system to ensure vaccines met production standards. Other areas of noncompliance involved the validation of terminal sterilization and inactivation processes. Sterility tests and process validation were not conducted as well.

Angulema is prohibited from supplying batches and must recall all batches already distributed in Spain. It faces a full suspension on its manufacturing authorization and temporary suspension on its importation authorization, the AEMPS said.

The FDA adopted ICH Q10 for good reason: The lifecycle approach to drug GMP promises to improve quality across the board. A Process Approach to Pharmaceutical Quality Systems: A Guide to ICH Q10 Compliance report from FDAnews helps you bring your drug manufacturing quality systems into compliance.

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