- The Food and Drug Administration has issued a warning letter to Barcelona-based active pharmaceutical ingredient (API) maker Interquim SA for violations of good manufacturing practices (GMP) that threatened the quality control of its products.
- The letter, dated Nov. 22 and released last week, called out the company for its response to an agency inspection in May. The inspection found Interquim failed to keep its equipment sufficiently cleaned, properly address deteriorating equipment and provide necessary stability data.
- But the company's solutions, laid out in a May 27 response to the FDA, weren't good enough, according to the agency. For example, Interquim added an extra step in its cleaning procedure to eliminate leftover residue in some drug production equipment, but did not detail whether the added step was effective.
"In addition, you did not determine if your cleaning procedures are effective for all API that you manufacture on your non-dedicated equipment," the FDA said in the warning letter. "You did not define the acceptance criteria for carryover of residues."
The FDA also poked holes in Interquim's other plans of action.
To address discoloration in aging equipment, the company had its maintenance contractor repair the tarnished pieces with a new material. The agency argued, however, Interquim did not specify how effective the new material would be or if it could affect the quality of the API it helped to produce.
The FDA also said the Interquim's reply never included the initially missing stability data. Without that data, "you cannot assure that your reprocessed API meets specifications throughout its assigned shelf life. This could adversely affect the quality of the drugs that your customers manufacture from your API," the agency said in the letter.
To remedy those situations, the agency asked the company to outline the efficacy of its updated cleaning procedure and provide an overview as to how the older plan could have contaminated the API, as well as a date that those actions would be completed.
What's more, the FDA requested the company investigate the source of its discolored equipment, and explain how the fixed equipment is ready for drug production.