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  5. 9.0 - Retention Requirements of GMP Records and Reports
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  • <Drawer cabinet full of green suspension files in numerical order, numbered with bright yellow tabs. Credit> AdobeStock_451517968
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  • <Gold DVD disc for maintaining electronic records. Credit> AdobeStock_316729225
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  • <Rows of IT servers behind glass doors either side of a metal walkway, with artist impression of wireless information transmitting as coloured lines and dots. Credit> AdobeStock_286399174
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  • <Old records on magnetic tape storage kept in boxes with barcode numbers. Credit> AdobeStock_386856509
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By GMP-SOP-Download Drug

9.0 - Retention Requirements of GMP Records and Reports

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Any production, control, or distribution record associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products exempted from expiration dating, 3 years after distribution of the batch, readily available for authorized inspection

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<Operator following a master manufacturing record MMR adding brown colour to other ingredients in a white bucket with air stirrer creating a swirl effect. Credit> AdobeStock_269910716
GMP-SOP-Download Drug9.1 - Records and Reports - Production Records
<Female employee filing records in box files on a shelf. Credit> AdobeStock_73250678
£19.99 GBP
£19.99 GBP