FDA WARNING LETTER | Failure to prepare adequate batch production records and record the activities at the time they are performed.

The U.S. Food and Drug Administration (FDA) has inspected the Chinese drug maker Changzhou Jintan Qianyao Pharmaceutical facility at No. 678 Zhuangcheng, Changzhou, Jintan, from February 13–17, 2017.

 

The inspection has concluded with few GMP violations and influenced for a warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).

During our inspection, our investigator observed specific deviations including, but not limited to, the following.

 

1.    Failure to implement a system for managing quality encompassing the organizational structure, procedures, processes and resources, as well as activities to ensure confidence that the API will meet its intended specifications for quality and purity. Failure to define and document all quality-related activities.

 

Before August 2016, your firm did not have any quality-related procedures in place even though you were manufacturing and shipping drugs to the United States. Although you had drafted some procedures by the time of our February 2017 inspection, you had not yet implemented any such procedures as of the date of our inspection.

 

2.    Failure to have adequate written procedures for the receipt, identification, quarantine, storage, sampling, testing, handling, and approval or rejection of raw materials.

 

For example, when our investigator asked for a list of your critical raw materials and your sampling requirements, you told our investigator that you had no written procedures for testing and sampling incoming materials. Instead, you explained, your warehouse employees accounted for incoming raw material handling, sampling, and testing “in their heads.”

 

3.    Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.

 

For example, our investigator reviewed the audit trail from your assay testing for (b)(4) lot (b)(4), and found that you tested the same sample set three times over several days without documentation or investigation. You reported only the result of the third and final test for purposes of completing your certificate of analysis and releasing this batch of API.

 

4.    Failure to prepare adequate batch production records and record the activities at the time they are performed.

 

For example, our investigator found that your operator used process parameter values from previous batches of (b)(4) to complete new batch records when she was too tired to immediately record the data and had forgotten the values.  

For more detailed information please click here for actual warning letter

Source: FDA

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