16.0 - GMP Records for Supplements supplier approval Any physical plant you use

Any physical plant you use in the manufacture

Such specifications must be met

quality and purity is met

or other extraneous material

SOP and report form for tablet or capsule dissolution testing of by Quality Control according to USP <711> and EP 2

16.0 - GMP Records for Supplements supplier approval Any physical plant you useYou 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