Europe – 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…