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Home » Spanish Authorities Seek to Suspend EU Lab Certificate Over GMP Violations
Spanish Authorities Seek to Suspend EU Lab Certificate Over GMP Violations
September 30, 2016
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.
Alcor proposed a corrective action plan in July, but inspectors determined in August that the proposed actions were insufficient.
Despite the findings, Spanish regulators say a recall is not necessary because the company’s manufacturing activities are limited.
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