Manquements sévères pour ce fabricant d'API chinois

2.    Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.  

Our investigators observed systemic data manipulation across your facility. They documented unexplained deletions of laboratory test results. They discovered that you repeated tests until you obtained acceptable results and that you failed to investigate out-of-specification or otherwise undesirable test results. Your firm relied on these falsified and manipulated test results to support batch release and stability data. Your firm routinely re-tested high performance liquid chromatography (HPLC) samples and deleted previous chromatograms without justification. Your management acknowledged that employees in your quality control laboratory have access, authority, and the ability to delete and repeat HPLC injections when undesirable results were encountered prior to reporting final results...

Reducing the number of records on your hard drives is not a sufficient justification for excluding data. Your response is inadequate because you have not shown how you will correct the data manipulation and falsification practices discussed above, nor have you demonstrated how you will ensure that all CGMP test results are retained and considered by your quality unit as a part of batch release.

3.    Failure to ensure that all quality-related activities are recorded at the time they are performed.  

In the production area, our investigators witnessed an employee backdating production batch records for seven batches of (b)(4) (batches (b)(4) to (b)(4)) and transcribing data from a master template record. Furthermore, analysis of the transcribed data for these seven (b)(4) batches and for approximately 40 batches of (b)(4) API, indicated that you did not record data contemporaneously and that missing data was later falsified so the official records would appear complete.

In the laboratory area, our investigators observed a laboratory analyst attempting to remove a large pile of loose documentation from the HPLC instrumentation room. Upon reviewing the pile of documents, investigators found a significant number of partially completed quality control data worksheets and scratch-paper records containing sample weight values. Our investigators compared these to the official quality control data worksheets and found numerous discrepancies in weights and calculations...

4.    Failure to maintain batch production and laboratory control records to determine compliance with established API specifications before a batch is released or distributed.

On November 16, 2015, you told our investigators that you had stopped manufacturing (b)(4) API in September 2015. However, during our inspection, our investigators reviewed HPLC and gas chromatogram electronic audit trails that indicated you conducted multiple HPLC and GC analyses on (b)(4) batches of (b)(4) API from November 5 to 6, 2015 (batch numbers (b)(4) to (b)(4)).

By your batch numbering system, these batch numbers correspond to batches manufactured in November 2015, two months past the date that you said you ceased production. During the inspection, you could not provide batch production records for these batches, nor did your instrument-use logbooks reflect the testing of these batches. Furthermore, the assay and related substance injection results for these (b)(4) batches had been deleted, according to your laboratory analyst, and could not be produced for review during the inspection...

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