The QMN Weekly Bulletin

Spanish API Maker Ercros Warned for GMP, Validation Problems

Aug. 10, 2012

The FDA has warned Spanish industrial giant and active pharmaceutical ingredient (API) maker Ercros S.A. for GMP nonconformities, including various validation lapses and building disrepair that invites pests.

Ercros, a leading producer and exporter of fosfomycins for use in antibiotic drugs, was reprimanded in part because its response to a July 2011 inspection of its Aranjuez (Madrid), Spain, facility was inadequate, the recently posted warning letter states.

Concerns about the purity of the plant’s purified water system account for two of the letter’s six observations. Ercros failed to validate the performance of the water system, which provides water for API products used to make sterile drug products, FDA investigators say.

While the FDA has its own policies and focus areas for process validation, the EMA goes about it another way. If the EMA inspectors visited tomorrow, would you pass or fail?

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