GDP Non-compliance Report issued in EudraGMDP

Recommendation

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The competent authority of the Czech Republic entered in total three GDP non Compliance Report into the community database for GMP and GDP compliance. While GMP Non-Compliance Reports are entered frequently, reports about GDP compliance issues are not published very often.

The first concerned company is First Pharma s.r.o. The warehouse is in Alliance Healthcare s.r.o., Podle Trati c.p. 624/7, Praha 10 - Malešice, 108 00, Czech Republic. According to the inspectors: "From the knowledge gained during inspection of this wholesale distributor, the latest of which was conducted on 2016-04-21, it is considered that it does not comply with the Good Distribution Practice requirements referred to in Article 84 of Directive 2001/83/EC." No further details have been published about the details of the findings.

The second concerned company is Duchcovská distribucní s.r.o., Nemocnicní 264, Duchcov, 419 01, Czech Republic. Also here no further details have been provided about the reasons of the GDP Non-Compliance. The latest GDP Non-Compliance Report refers to WebCash s.r.o., warehouse is in Námestí Práce 1099/1, Zlín, 760 01, Czech Republic. According to the report the company failed to use authorized storage facilities. Also the company has not ensured "the services of a qualified person". This might be translation error because a Qualified Person is not needed for a GDP facility but a "Responsible Person". The wholesale authorisation was suspended for all three companies.

Still, GDP Non-Compliance Reports in EudraGMDP are an exception. But this does not mean that inspections always confirm the GMP status. The simple reason is the lack of data entered into the database. This becomes obvious when one looks at the country data entered into the database. Germany counts only 73 GDP compliance reports. And this is only a fraction of the total number issued. The same applies for many other countries as well. Still, the EU needs to work on the procedure to make sure that both GDP compliance and GDP non compliance data will be entered by the competent authorities in the EU. Only if data entry is made complete the goal of the database can be achieved. For example, wholesalers and pharmaceutical companies can then use the database to check whether customers or suppliers have a valid GDP certificate.

Source: EudraGMDP Database