Spanish API Maker Lands Warning Letter for GMP Deficiencies
The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards.
As a result of those deficiencies, investigators noted that interior surfaces of the firm’s drug manufacturing equipment were not cleaned in accordance with the company’s standard operating procedures.
FDA investigators also found the company did not provide 12-month stability data for reprocessed APIs, calling into question whether those ingredients meet appropriate quality specifications.
Furthermore, the warning letter states that there was residue on some of the company’s surfaces, which can lead to contamination, as well as discolored interior surfaces, indicating deterioration.
In a response to FDA, the company acknowledged that residue resulted from the inadequate cleaning of the equipment. Interquim said it has revised its cleaning methods, but the FDA noted that, although changes have been made, the procedures have not been validated for effectiveness.
Additionally, the company said it has replaced several of the discolored surfaces observed in the inspection. The firm however, did not provide a root cause for the discolorations, prompting the FDA to ask for further details. The company also did not show how it plans to collect stability data and ensure its preventative maintenance is suitable for manufacturing.
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