GMPSOPDownload Dietary Supplements

16.0 - GMP Records for Supplements

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You must keep written records required by this part for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records. You must have all records required  readily available during the retention period for inspection and copying by FDA when requested

<Female employee next to a laptop, wearing blue shirt and black skirt, holding a box folder of dietary supplement records taken from a shelf behind her. Credit> AdobeStock_73250678
<Open cabinet drawer containing over 30 green cardboard hanging file folders individually numbered and in numerical order with 8 digits starting in 6211. Credit> AdobeStock_451517968
<Back of a male employee, wearing a denim coloured shirt, scratching his head trying to think in front of two tall shelf units full of blue A4 box folders. Credit> AdobeStock_146037976
<A video camera in production behind a perspex screen recording the performance of a filling line and how rejects may occur. Credit> AdobeStock_302586687
<Two wooden shelf units full of paper GMP records stored in booklets. Credit> AdobeStock_293074565
<Large futuristic IT server units behind glass panels for keeping electronic GMP records with artistic impression of information flowing through them as yellow dots and green, red and blue lines. Credit> AdobeStock_286399174
<Gold CD disk on grey checked background for keeping dietary supplement GMP records. Credit> AdobeStock_316729225