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CMC Issues Again

Several previous blogs have discussed the importance of maintaining quality oversight of a contract facility to the drug development timeline. Below is an example of a generic manufacturer with problems maintaining quality oversight of its own multiple sites.

Apotex, the Canadian generic manufacturer received a CMC based warning letter on March 29th. This recent warning letter was prompted by insufficient responses from Apotex to inspection violations. The FDA said Apotex’s responses are inadequate and lack sufficient corrective actions. The issues in this warning letter highlight major cGMP violations, the primary factor being repetition of the same violation at multiple sites with no clear resolution for future prevention.

The warning letter contains more than one example of the use of a portion of a rejected API batch in the manufacture of final drug product. The final product was released for distribution and shipped to the US in each instance.

The firm was cited for not having adequate written procedures for commercial production and process controls to support the identity, strength, quality, and purity of the drug products they are manufacturing. Several failed manufacturing validation runs were cited as examples. Material identified as defective during the investigation of the run failures were used in other lots of product which were released for distribution.

Apotex has fifteen days from the receipt of the warning letter to notify the FDA in writing of the specific steps to be taken to correct these violations. Do not take your product quality for granted.