2. Failure to maintain complete data derived from all laboratory tests conducted to ensure your API and intermediates comply with established specifications and standards.Oops! Sorry! Never happen again, I promise.
Your firm performed HPLC assay testing for [redacted] API release to the United States, along with stability and intermediate testing, on your Waters HPLC system between September 25, 2011, and May 5, 2017. Official quality control data packages presented to the quality unit for batch disposition decisions reported the results of testing performed during this timeframe on this equipment. During our inspection, when we sought to reconcile assay results reported in the quality control data package for a released batch with the underlying electronic data, you responded that you could not provide the electronic data from laboratory analyses on this equipment for the above period of several years. You explained that the electronic data in question had been deleted by accident and was no longer available. (emphasis mine)
In your response, you stated that the electronic data had been downloaded to a “mobile hard disk for backup” and that you would be able to recover the data after you have upgraded your HPLC software. However, you did not include evidence to support recovery of deleted electronic data or demonstrate how you will prevent such deletions from recurring in the future.
Wednesday, April 25, 2018
Warning Letter of the Week: accidental deletion edition
A friendly note to the president of Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. in Yunnan, China from the folks at the Center for Drug Evaluation and Research: