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  • <Laboratory analyst wearing blue gloves conducting an OOS investigation by completing a phase 1 form. Credit> AdobeStock_391585993
    AdobeStock_391585993
  • <Row of white digital analytical balances for weighing to four decimal places with clear glass guards and steel weight plate. Credit> 147005408 © Ryzhov Sergey | Dreamstime.com
    147005408 © Ryzhov Sergey | Dreamstime.com
  • <Two graphs showing out of specification results for vitamin C, one for a QC batch release result, the other for two stability time points, one above specification limit and the other below. Credit> GMP-SOP-Download.com
    GMP-SOP-Download.com
  • <Two graphs showing results that are within specification but are out of trend with the other results for vitamin C, one for QC batch release testing and the other for stability time points. Credit> GMP-SOP-Download.com
    GMP-SOP-Download.com
  • <Graph showing atypical or out of trend OOT stability results where one particular batch is degrading much faster in ferrous iron than all previous batches stability tested. Credit> GMP-SOP-Download.com
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8.4 - Laboratory Controls - OOS Investigation and Form

$48.00 USD
$48.00 USD
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An out of specification investigation must be completed each time a laboratory test, examination or the result of any monitoring fails to meet an established specification; one investigation per OOS test parameter. This applies to physical, chemical, & microbiological tests or examinations, stability testing, monitoring, and validation

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<Laboratory analyst wearing blue gloves conducting an OOS investigation by completing a phase 1 form. Credit> AdobeStock_391585993
$48.00 USD
$48.00 USD