Regulatory Focus™ > News Articles > 2019 > 7 > Spanish Regulator Revokes GMP Certificate of Generic Drugmaker

Spanish Regulator Revokes GMP Certificate of Generic Drugmaker

Posted 08 July 2019 | By Zachary Brennan 

Spanish Regulator Revokes GMP Certificate of Generic Drugmaker

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) last month issued a statement of noncompliance with Good Manufacturing Practice (GMP) and revoked the GMP certificate of Barcelona-based generic drugmaker Novocat Farma.

Following a 4 June inspection, the statement of noncompliance, issued 27 June, said the site does not have a technical director or substitute technical director.

“During the period when the technical director was on sick leave, there are documents presumably signed by her in which the signature is falsified,” the statement says. “The quality assurance system has stopped working on a regular basis since January 2019, as they have stopped recording the deviations and out of specifications results obtained in the quality controls of the drugs they carry out.”

In addition, the regulator found that the quality control laboratory’s procedures are not adequately followed to ensure compliance with GMP in the analysis of medicinal products.

Novocat Farma did not respond to a request for comment.

EudraGMDP

Tags: AEMPS, GMP, Novocat

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe