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.

The FDAnews DVD GMP Training for Drugmakers is designed to provide the kind of high-level employee education everyone wants, with the flexibility that makes in-house training most beneficial.

View today's stories