WL International Trading Pharm Lab Inc MARCS - APRIL 24, 2020
1. Failure of your quality unit to ensure that drugs are appropriately tested and the results are reported.
Your quality unit did not provide appropriate oversight to laboratory operations. Several chromatographic injections of samples and standards associated with an out-of-specification (OOS) investigation were not included in your investigation, reviewed by your quality unit, and communicated to your client.
For example, four (b)(4) samples tested OOS for assay on October 24, 2017. As part of the OOS investigation, they were all retested on November 11, 2017. One of the four samples you retested as part of your OOS investigation, (b)(4) sample ID (b)(4), was re-injected in
duplicate under a separate series for assay approximately 14 hours later that same day. The second data set was not captured in the analyst’s notebook, it was not included as part of your documented OOS investigation, and your quality unit (QU) was unaware of the sample re-injection.
duplicate under a separate series for assay approximately 14 hours later that same day. The second data set was not captured in the analyst’s notebook, it was not included as part of your documented OOS investigation, and your quality unit (QU) was unaware of the sample re-injection.
In addition, (b)(4) sample ID (b)(4) was tested a second time with injections labeled in part “Experimental” with unknown results obtained, and also was not included as part of your official OOS investigation...
2. Failure to establish and follow written procedures for investigating critical deviations or the failure of API batches to meet specifications.
Your firm’s investigation of OOS results was closed without adequate scientific justification. For example, OOS results were obtained during testing of four (b)(4), United States Pharmacopeia (USP) samples starting on October 24, 2017. Your investigation determined there was an unknown peak co-eluting with the (b)(4) peak. However, this determination was not scientifically justified: the sample solution determined to have a co-eluting peak was approximately 15 days old when it was tested. You lack data on solution stability to show that the co-eluting peak was not caused by the age of the sample solution...
3. Failure to verify the suitability of analytical methods.
Your firm failed to ensure that methods used for analyzing drug samples had been verified as suitable for their intended use. For example, your firm conducted (b)(4) assay, (b)(4) assay, and identity A testing on multiple (b)(4) API samples following USP methods without verifying their suitability under actual conditions of use...
4. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.
Your firm lacks controls to assure the integrity of electronic test data generated by high performance liquid chromatography (HPLC) and gas chromatography (GC) systems. For example, during the inspection our investigator observed that stand-alone computers used to run an HPLC and a GC allowed analysts who test drug samples the ability to delete raw data files and alter date and time stamps. In addition, audit trails were not enabled, so there would be no way to determine whether analysts manipulated data.
Customers rely on the integrity of the laboratory data that you generate. You also need traceability of actions for investigational purposes. It is important to maintain strict control over CGMP electronic data to ensure that all additions, deletions, or modifications of information in your electronic records are authorized and appropriately documented...
