1. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP, and meet established specifications for quality and purity.Seems legit.
Your quality control laboratory disregarded multiple out-of-specification (OOS) impurity results without justification. For example, on September 22, 2015, you encountered an OOS unknown impurity peak during high performance liquid chromatography (HPLC) testing of [redacted] 36-month stability batch [redacted]. You terminated the analysis. Testing of a new sample also showed the OOS impurity peak. The chromatogram was then manually rescaled, which hid the presence of this peak. Your laboratory set the integration parameters to omit this peak from integration. Because the peak was omitted, the quality unit was not provided with full information to evaluate whether the stability batch, and potentially other marketed batches, continued to meet quality standards.
In addition, your audit trail showed that from July 1 to 2, 2015, you performed seven sample injections of [redacted] 60-month stability batch [redacted] to test for impurities using HPLC. You permanently deleted the first five sample injections. You then renamed the last two injections and reported that they met specifications. [emphasis CJ's] Your quality unit failed to identify and address these serious data manipulations.
Wednesday, March 22, 2017
Warning Letter of the Week: renaming samples edition
A dispatch from the Center for Drug Evaluation and Research to the general manager of Jinan Jinda Pharmaceutical Chemistry Co., Ltd.: