Entry in EudraGMDP means Production Stop for a Slovakian Company

In January 2023, an inspection by the local authority was carried out at a Slovakian pharmaceutical company. Three critical deficiencies, a corresponding entry in the EudraGMDP database and the withdrawal of the GMP certificate were the result. The Qualified Person (QP) was also mentioned. The QP had confirmed in a statement that the production of paracetamol and ibuprofen-containing preparations for further processing into suspensions and suppositories complies with the requirements of good manufacturing practice (GMP). The problem was that the authority saw things differently during the inspection. According to the entry in the database, a combination of several deficiencies "demonstrates non-compliance with GMP requirements in the manufacture of medicinal products":

  • Possible cross-contamination risks were not assessed
  • Primary production documentation was not submitted
  • The production activity carried out for a customer was not clearly defined
  • The control of raw materials was not carried out according to the company's procedure. Also, the raw materials were not approved by the QA department
  • The identity of the raw materials was not verified
  • No control samples of the product were taken

But that's not all; it was further found that the preparation of suspensions and suppositories did not comply with the manufacturing authorisation. Approval procedures were not followed, nor were the legal requirements of the national authority for the manufacture of active ingredients. The preparation of oral suspensions was done in a facility without proper qualification and the homogenisation of the prepared suspension was not verified.

What happened with the QP is not stated in the report.

Source: EudraGMDP Database (Inspection Date: 25 January 2023; Report Number: SK/001NC/2023, Reference Number: 157483)*

* To find the respective report, please click on "Non-Compliance Reports" in the database menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.

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