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  5. 8.4 - Laboratory Controls - OOS Investigation and Form
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  • <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
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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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GMP-SOP-Download Drug8.3 - Laboratory Specifications
<Bottle of capsules labelled Identity, one of the drug specification requirements, on a white table with a blurred pharmacy and pharmacist background. Credit> Freepik
<One half of picture pipetting clear liquid into blue glass bottles, the other half shaking a conical flask containing bright, clear amber liquid, all against a subtle background of the periodic table of elements. Credit> AdobeStock_101292718
GMP-SOP-Download Drug8.5 - Laboratory Controls - Physical and Chemical Testing
<Laboratory analyst wearing blue gloves conducting an OOS investigation by completing a phase 1 form. Credit> AdobeStock_391585993
$48.00 USD
$48.00 USD