Is there anything like European Warning Letters?

Recommendation

4/5 October 2023

Advanced Level: Trending of Process Data for OPV/CPV - Live Online Training

European Warning Letters? Is there such a thing? Basically, no. Warning Letters are issued by the US-American FDA. However, there is something "comparable" namely the "Non-Compliance Reports" published in the EudraGMDP database. These reports are generated by the competent authorities, which conduct GMP inspections at the premises and upload their reports into the database. Now, one may question what the authorities has complained about in the last three months.

In this period, several Non-Compliance Reports were published for both European and non-European manufacturers. The European companies in question are located in the Czech Republic, Denmark, Italy and the Netherlands. The non-European locations with deficiencies were located in India (two companies) and China.

The GMP deficiencies are classified as "critical", "major" and "other", whereby only "critical" and "major" findings are usually listed in the reports. The following deficiencies were found, among others:

• Mould in production rooms
• No Deviation System and Change Control System
• Cross-contamination issues
• Reworking (API)
• Deficiencies in aseptic manufacture
• Lack of management review
• No trend analysis
• No/or inadequate self-inspections
• Missing CAPA system
• Deviations from the CEP   

The difference to FDA Warning Letters is that Non-Compliance Reports are final decisions about a GMP non-compliance. Warning Letters are a warning - allowing companies to react. You can find the complete list of Non-Compliance Reports in the EudraGMDP database. Please also see the latest GMP Non-Compliance Reports.