The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 10 > EU Regulators Send Statements of Non-Compliance for Drugmakers in Spain, Italy, India

EU Regulators Send Statements of Non-Compliance for Drugmakers in Spain, Italy, India

Posted 29 October 2018 | By Zachary Brennan 

EU Regulators Send Statements of Non-Compliance for Drugmakers in Spain, Italy, India

A handful of statements of non-compliance with good manufacturing practice (GMP) have been posted to the EudraGMDP database, including ones sent to Spain’s Genfarma Laboratorio, Italy’s Biomedica Foscama Group and India’s Mercury Laboratories.
For Mercury, the competent authority from Malta found one critical deficiency, six major deficiencies and 13 other deficiencies during its inspection.
“The critical deficiency concerned authenticity of records which could not be verified including
production records and quality risk assessment records,” the Medicines Authority said. “The major deficiencies were cited for highly deficient production activities, process validation that does not provide assurance that the medicinal product consistently produces a product meeting its specifications and quality attributes, deficient supplier approval systems, quality control and microbiology laboratory deficiencies, inadequate pharmaceutical quality system and documentation management and inadequate cleaning validation to ensure no cross contamination.”
As a result of the inspection, Malta’s Medicines Authority recommends that marketing authorization applications or variation applications to current marketing authorizations to include the Indian manufacturing site should not be considered.
Meanwhile, the Italian Medicines Agency inspected Biomedica Foscama Group and found 17 major and one other deficiency.
The major deficiencies were related to an inadequate pharmaceutical quality system that resulted in the following issues: “lack of environmental qualification of the aseptic manufacturing areas and a lack of qualification of critical equipments (e.g. autoclaves, depirogenation tunnels, lyophilisers, ampoules leak testing machines, filter integrity tester, visual inspection machines).” In addition, QC equipment were not qualified and data integrity was not assured. Batch release was also executed without finalizing the batch record review.
And for Genfarma, which was inspected by the Spanish Agency of Medicines and Medical Devices as part of a for-cause inspection in late July and August, the regulators found 38 deficiencies, including 15 classified as critical and 19 classified as major.
“A lack of EU-GMP compliance was detected during the inspection,” the non-compliance statement said. “In general, critical and major deficiencies were related to Pharmaceutical Quality System, manufacturing processes, quality control activities and sterility assurance that could lead to a significant risk of producing a product which is harmful to the human patient, since the quality of the sterile medicinal products manufactured cannot be assured. The severity of the critical and major deficiencies detected and the level of EU-GMP non-compliance are such that the inspectors´ team recommend that interim supervisory measures are taken to remove a potential risk to public health.”

Regulatory Focus newsletters

All the biggest regulatory news and happenings.