• <Male employee with back to camera scratching the back of his head looking for some quality records in a shelving full of blue lever arch folders. Credit> AdobeStock_146037976
    AdobeStock_146037976
  • <Laboratory analyst entering data electronically by white keyboard on the laboratory information management system LIMS next to a test tube rack with three blue tubes. Credit> Freepik
    Freepik
  • <White wooden shelves full of completed laboratory notebooks, records that must be maintained whilst the related product is marketed. Credit> AdobeStock_293074565
    AdobeStock_293074565
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<Male employee with back to camera scratching the back of his head looking for some quality records in a shelving full of blue lever arch folders. Credit> AdobeStock_146037976
<Laboratory analyst entering data electronically by white keyboard on the laboratory information management system LIMS next to a test tube rack with three blue tubes. Credit> Freepik
<White wooden shelves full of completed laboratory notebooks, records that must be maintained whilst the related product is marketed. Credit> AdobeStock_293074565

GMP-SOP-Download Drug

9.4 - Records and Reports - Quality Records

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Quality records must be maintained for one year after expiry of the last batch implicated, including but not limited to batch disposition decisions, investigations into non-conformances, OOS investigations, change controls, CAPA, returns, complaints, recalls, pest control, internal audits, supplier audits, and records of all training and qualifications

&lt;Male employee with back to camera scratching the back of his head looking for some quality records in a shelving full of blue lever arch folders. Credit&gt; AdobeStock_146037976
&lt;Laboratory analyst entering data electronically by white keyboard on the laboratory information management system LIMS next to a test tube rack with three blue tubes. Credit&gt; Freepik
&lt;White wooden shelves full of completed laboratory notebooks, records that must be maintained whilst the related product is marketed. Credit&gt; AdobeStock_293074565