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News about GMP/cGMP

2016-12-13

FDA: Warning Letter for Spanish API Manufacturer

The US FDA (Food and Drug Administration) released a warning letter sent to Interquim S.A., Barcelona, Spain. The drug manufacturing facility was inspected in May 2016. It summarizes significant deviations from current GMP for active pharmaceutical ingredients (APIs).

 

The warning letter lists the three following observed specific deviations:

  • Failure to have adequate cleaning procedures that define and justify acceptance criteria for residues.
  • Failure to construct equipment so that surfaces that contact raw materials, intermediates, or API do not alter the quality of API beyond established specifications.
  • Failure of the quality unit to ensure that there is stability data to support retest or expiry dates and storage conditions on API and/or intermediates.
FDA doesn’t consider this to be an “all-inclusive list”. Interquim is now responsible for investigating these deviations for determining the causes, for preventing their recurrence, and for preventing other deviations.

Source:
FDA: Warning Letter
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