GDP Issues cited in Non-Compliance Report
Recommendation
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A new Non-Compliance Report 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 and that there is a "lack of will and ability to adhere to the principles" of Good Distribution Practices (GDP):
This was also based on the following observations:
- Inadequate control for falsifications and temperature excursions during transportation upon receipt of medicinal products
- Deficient procedures for qualification of transporters/forwarders
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.
Source: EudraGMDP Database (Non-Compliance Reports, Report No: 2017090955)
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