Ce fabricant d'API chinois épinglé par l'US FDA...
1. Failure to have laboratory control records that include complete data derived from all tests conducted to ensure compliance with established specifications and standards.Plus d'information ici.
Your laboratory personnel conducted unofficial testing without appropriate documentation, justification, and investigation.
Our inspection found that analysts performed multiple gas chromatography (GC) analyses of (b)(4) samples for residual solvents. Analysts performed these unofficial analyses and recorded them in separate “R&D” folders before conducting the officially reported sample analyses. The original, unofficial analyses stored in separate R&D folders were not part of the official quality control records for your API, and your firm did not consider the results of these unofficial analyses to evaluate the quality of your API or make batch release decisions for numerous batches of API.
Our investigator reviewed chromatograms found in the R&D folders and noted that some displayed large unknown peaks that were not reported in the official records for the same samples. The presence of such peaks in the chromatograms may indicate the presence of unknown and uncharacterized impurities (including potential contaminants) in your drugs.
In your response, you stated that from April to July 2013 you performed “pre-trial” sample analyses for residual solvent testing of (b)(4) batches to check system suitability. You also stated you were not testing into compliance and attempted to attribute the unknown peaks found in your “pre-trial” sample analyses to operator error. FDA considers the use of an actual sample in test, prep, or equilibration runs as a means of disguising testing into compliance, a violation of CGMP.
2. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to provide adequate controls to prevent omission of data.
Our investigator found that your GC system used to test for residual solvents in (b)(4) lacked controls to prevent manipulation, data deletion, and unauthorized access. For example, operators responsible for generating CGMP records had full administrator rights to access the computers containing temporary data prior to routine transfer of the data to a server. All analysts shared a common login ID and password. Your use of universal administrator privileges and a single common login/password meant that actions could not be traced to specific individuals. Additionally, because the audit trail feature on the system’s software was not configured to create a file history for all activities executed by the user during analysis, your electronic data was exposed to manipulation and/or deletion without traceability.
3. Failure to record activities at the time they are performed.
During the inspection, our investigators observed (b)(4) different analysts pre-dating or backdating results in your API quality control laboratory. Analysts were observed using pre-dated laboratory worksheets to document system suitability testing for high performance liquid chromatography (HPLC) analyses for (b)(4) purity testing. The worksheets were dated five days before the tests that they purported to document were actually carried out. Our investigators also observed analysts signing and dating microbiological testing laboratory worksheets five days before the test results would be available and backdating laboratory worksheets for impurities and content testing by four days.
