Media Fill issues cause Non-Compliance Reports for Spanish Manufacturers

Recommendation

18/19 June 2024
Copenhagen, Denmark

Environmental Monitoring
Compliant and Reasonable

The EMA (European Medicines Agency)  published two Non-Compliance Reports for the Spanish companies Euro Far Alergi S.L. and Angulema S.L. in Madrid. The Spanish national competent authority "Spanish Agency of Medicines and Medical Devices" inspected both companies and found several critical and major deficiencies. Those ultimately lead to a suspension of the MIA, the recall of all produced batches and a prohibition of supply.

Non-compliance reports are published in the EudraGMDP database of the European Medicines Agency (EMA) by European national competent authorities. They refer to inspections inside as well as outside of the European Union. The non-compliance reports are independently submitted into the database by National Competent Authorities via a standardised form. For the company concerned, a non-compliance report has severe consequences until the violations are rectified. Amongst other things, a suspension of the marketing authorisation as well as recalls of the products in question could be mandated.

List of the deficiencies found at Euro Far Alergi, a manufacturer of aseptic autovaccines as well as individual vaccines made from bacterial and allergenic extracts

• Materials are not controlled upon receipt
• Physical and chemical specifications of finished products were not controlled
• The sterility test was not correctly validated
• The Media Fill does not show that the process is performed under aseptic conditions
• The environmental monitoring, cleaning and disinfection and general hygiene of gowning were not compliant with GMP requirements
• The inactivation process of bacterial vaccines and autovaccines wasn't validated
• The premises were not compliant with Part 1 of the EU GMP Guideline and Annex 1

List of deficiencies found at Angulema, a manufacturer of immunological products

• There was no effective pharmaceutical quality system in place
• Products for subcutaneous administration were released without performing a sterility test
• Process validation had not been performed
• Media Fill for the aseptic process had not been performed
• Validation of the terminal sterilisation had not been performed
• The inactivation process of bacterial vaccines and autovaccines had not been validated

Source: EMA EudraGMDP database (see "Non-Compliance Report")