Non Compliance Report for Deficiencies in Contamination Control

Based on the results of an inspection on 28 and 29 April of this year at the Polish pharmaceutical manufacturer Przedsiebiorstwo Produkcji Farmaceutycznej GEMI Nowakowski Grzegor, a corresponding Non-Compliance Report was recently published at the EMA.

The medium-sized manufacturer of non-sterile pharmaceutical products such as liquids, semi-solid forms, tablets, but also herbal products was inspected by the responsible inspectorate at the end of April. Two critical and 10 major deficiencies were identified during the inspection. These ranged from insufficient measures to prevent contamination by fungi and bacteria or to avoid cross-contamination, to inadequate measures for monitoring contamination. The concepts for any necessary investigations within the framework of quality control in the event of deviations were also inadequate. Furthermore, the manufacturer did not have the necessary premises for the storage of pharmaceuticals under controlled conditions.

As a result, the manufacturing license was suspended, the GMP certificate was withdrawn and several batches of already released products were recalled due to non-compliance with the quality requirements of the specification for the parameter microbiological purity - total yeast and mould count (TYMC).

Further details can be found in the current Non Compliance Report at the EMA Website.

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