Validation Times - Chinese API maker looks to state for calibration service
FDA’s May 28-June 1, 2001, inspection of API make Northeast General Pharmaceutical Factory of Shenyang, China, netted the maker of bulk sucralfate U.S.P. four citations on the Oct. 2 warning letter for stability records and calibration lapses. The Division of Manufacturing & Product Quality at the Center for Drugs informed the firm that CDER would recommend withholding approval of NDAs listing Northeast’s product as a component.
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The agency cited the firm for lack of documentation that would allow tracing of three samples of sucralfate used in stability testing back to the batches from which they were drawn. According to the warning letter, the three batches were produced after Northeast filed a “DMF amendment” [drug master file]. FDA commented that “data submitted in the amendment is different from data obtained for the release of these batches.” The agency added that Northeast could not “satisfactorily” explain the reason for its termination of the stability study.
Northeast’s response to the 483 apparently rebutted that the firm’s customer, Pharmaceutical International of Hunt Valley, MD, had completed the stability study out to 43 months, but the agency wanted to see it in writing. The 483 was penned by investigator John White and chemist Nasir Ali.
The warning letter noted that Northeast’s calibration of an HPLC did not include integrator and detector linearity, injector reproducibility or accuracy of temperature settings for the column heater and detector. A gas chromatograph took a calibration hit as well, with FDA stating that the calibration work did not include flow rate, temperature accuracy in the column, injector port temperature and reproducibility, and detector linearity. Doc. 10992W
FDA commented that Northeast would have to assure the reliability of calibration work undertaken by the State Measurement Institute, which the firm stated it would hire to handle calibration. The warning letter advised Northeast to revise its procedures accordingly, describing the lapse as “significant” and requiring “immediate corrective action.”
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