FDAnews
www.fdanews.com/articles/180009-spanish-regulator-suspends-manufacturing-authorization-of-drugmaker-for-gmp-lapses

Spanish Regulator Suspends Manufacturing Authorization of Drugmaker for GMP Lapses

January 13, 2017

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.

Today’s minor mistake by your supplier could easily turn into tomorrow’s major recall. And if you don’t catch all the oversights in your quality agreement, odds are the FDA will. Use 24 Elements of a Successful Supplier Quality Agreement to make sure you’ve covered all your bases and keep your suppliers well in hand.

View today's stories