Spanish Authorities Seek to Withdraw EU Lab Certificate Over GMP Violations

Spanish regulators want to temporarily suspend a laboratory’s EU certificate over a host of GMP deficiencies found at its facility.

The Spanish Agency of Medicines and Devices issued a noncompliance report to Guadalajara-based Alcor after a June inspection uncovered 29 GMP deficiencies at the lab, eight of which it classified as major.

The inspection found the facility did not meet EU’s GMP standards concerning: documentation practices; management of raw material suppliers’ and services providers; product and materials identification; periodic control of the critical aspects of operations through qualification and validation processes.