QP not present in Company: Prohibition of Supply

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

A new Non-Compliance Report (NCR, Report No: 2017090955) was published on the EudraGMDP site. On 21 September 2017, the Danish Medicines Agency performed an inspection at EuroPharma.DK ApS in Denmark. EuroPharma.DK ApS performs parallel import, repacking and distribution of pharmaceutical products.

During that inspection, it was considered that the secondary packing operations at the site do not comply with Good Manufacturing Practice. This was also based on the following observations:

• QP not present in company for supervision and competent interaction with staff and management
• QA department understaffed
• Inadequate follow-up and implementation of CAPAs
•  Insufficient handling of deviations and complaints
• Inadequate GDP implementation

As a consequence, the respective manufacturing authorisation was suspended and medicinal products must not be re-packed by EuroPharma DK or any of their contract manufacturers and must not be released and distributed. What's interesting is the fact that the GMP certificate which was withdrawn was just issued after an inspection on 8 March 2017.

Source: EudraGMDP Database (Report # 2017090955)