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New warning letter by FDA issued to Chinese API manufacturer Zhejiang Medicine Co. Ltd focus on data integrity

The focus of FDA's Warning Letter for the Chinese API manufacturer Zhejiang Medicine Co. Ltd. dated 4th August 2016 is on the lack of data integrity. A number of alarming findings were discovered in the course of the FDA inspection in June 2015 such as deletion of original data and unavailability of records of activities at the time when they were performed.

The FDA is now expecting concrete measures ("Data Integrity Remediation") from the company. For this, the FDA expressly recommended to retain qualified, external consultants. FDA wants the company to take the below listed actions:
• A comprehensive investigation of the extent of incorrect data which would include an extensive plan for the execution of the investigation, Interviews of current and former employees to clarify the root cause of incorrect data, an assessment of the extent of data integrity deficits and a comprehensive retrospective assessment of the performance of analytical testing.
• A current risk assessment of the possible effects of the deficiencies identified on the quality of the medicinal products, up to the risk to patients.
• A management strategy for the implementation of CAPA plans.


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