Impressive Non-Compliance Report for Romanian Drug Manufacturer

The European Health Agency EMA publishes Non-Compliance Reports by GMP inspectors in their EudraGMDP database. A report of impressive deficiencies at a pharmaceutical manufacturer's site in Romania based on an inspection in summer 2017 is available there, as well.

Overall, 12 deficiencies were rated "major". The list is quite long:

  • Inadequate CAPA system
  • No records for use of primary reference standards
  • No raw data of integrity and identity testing (of starting materials and finished products) available
  • No checks of the log-books in the laboratory
  • No records of the media preparation in the microbiology laboratory
  • No checks of the data entered into the Certificate of Analysis
  • Errors and deficiencies in the sampling documentation
  • Alterations of data in the log-book and obliteration of former entries; failure to mention the person who made the changes
  • Poor conduct of qualification and validation
  • Lack of process validation since 2011
  • Lack of cleaning validation of product equipment
  • Partly missing long-term stability studies
  • Batch Record entries are sometimes not made by the production employee who carried out the activity, but by the head of production at a later date

The most impressive (or shocking) sentence, however, is "lack of competent personnel in departments of QA, Production, QC, Engineering". This raises the question whether any of the GMP-regulating units employ competent personnel. It does not seem to be the human resources department.

This is correlated by the observation of the lack of training of key personnel.

The Romanian pharmaceutical company concerned may be relatively small and no large International Corporation, but the deficiencies are still alarming. Especially because the job market is empty of professionals with GMP experience (this is as true for Romania as it is for the rest of Europe), companies should once again build on long-term strategies for personnel development, as was customary in the 1970s and 1980s. The training of new employees by the "old hands" cannot be accomplished on the side, especially because this may take up to five years. In any case, the Romanian drug manufacturer has lost its manufacturing authorisation for now.

The Non-Compliance Statement from 23 June, 2017 can be found in the EMA's EudraGMDP database.

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