EMA non-compliance report on Indian manufacturer of sterile medicinal products

Recommendation

18/19 June 2024
Copenhagen, Denmark

Environmental Monitoring
Compliant and Reasonable

Non-compliance reports are published in the EudraGMDP database of the European Medicines Angency (EMA) by European supervisory 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.

On July, 5th 2017, the EMA published a non-compliance report on the Indian company Biocon Limited in Bangalore, which was inspected by the French supervisory agency "French National Agency for Medicines and Health Products Safety". During a pre-approval inspection, they observed 35 deviations in 3 Biosimilar-products, 11 of which were major deviations concerning the following topics:

• Environmental monitoring
• Employee training
• Handling of OOS results
• Cleaning validation
• Process validation
• Supplier qualification
• Media Fill tests 
• Cross contamination risks 
• Batch records
• Handling of differential pressure alarms in classified areas
• Access management in SAP for batch release

Alas, unlike in FDA warning letters, deficiencies aren't more closely specified. As a consequence of this inspection, the 3 products will get no marketing authorisation until the deficiencies are corrected.

Source: EudraGMDP database of the EMA