For a batch assay(By HPLC) test is analysed in ‘X’ instrument the result got OOS analyst not informed to supervisor or QC head and nothing documented reanalysed the same batch in ‘Y’ instrument the result got passed and documented the passed result submitted for review, supervisor reviewed the document he also not identified the gap, manager approved COA released and document submitted to QA. Now the question is how the AQA people will identify the batch is repeated twice or how we will trace? Please provide exact,correct, perfect answer for my question.
after analyst sign off the data in hplc, reviewer also sign off the data after checking results (OOS/OOT ) ,bracketing meets RSD criteria. Here reviewer can identify OOS if observed. Secondly in empower 3 software there is a early warning system in which a error code is generated if any line (batch no, AR No) is repeated twice . This msg is sent automatically to QA head, QC head and all the person concerned. There also one can identify why a batch analysis is repeated twice…