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  • <Hands of a laboratory analyst wearing blue gloves holding a pen and completing a phase 1 OOS investigation on a clipboard in blurred lab. Credit> AdobeStock_391585993
    AdobeStock_391585993
  • <Two vitamin C graphs, one showing a batch in a series with an OOS out of specification result, and the other showing a specific batch changing with time to become OOS. Credit> GMP-SOP-Download
    GMP-SOP-Download
  • <Two vitamin C graphs, one showing a batch in a series with an out of trend OOT result, the other a specific batch changing with time becoming OOT. Credit> GMP-SOP-Download
    GMP-SOP-Download
  • <Graph showing ferrous iron results of different batches over time on stability with one in particular showing an atypical additional degradation marked with arrows. Credit> GMP-SOP-Download
    GMP-SOP-Download
  • <Row of four white digital analytical balances with stainless steel weigh plates and glass screens. Credit> 147005408 © Ryzhov Sergey | Dreamstime.com
    147005408 © Ryzhov Sergey | Dreamstime.com
By GMP-SOP-Download Dietary Supplements

10.4 - Laboratory OOS Investigation & Form

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If the result of any test or examination fails to meet the established specification or trend, the lot and any other implicated lots must be quarantined and an out of specification (OOS) investigation conducted to determine the validity of the result. That lot may only be retested and released if the investigation clearly determines a laboratory error in the original result

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<Hands of a laboratory analyst wearing blue gloves holding a pen and completing a phase 1 OOS investigation on a clipboard in blurred lab. Credit> AdobeStock_391585993
£36.99 GBP
£36.99 GBP