21 CFR 111.140 - Under this subpart F, what records must you make and keep?
(1) Written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision and written procedures for approving or rejecting any reprocessing;
(2) Written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements by recording the following:
(i) Date that the review, approval, or rejection was performed; and
(ii) Signature of the person performing the review, approval, or rejection; and
(i) Identification of the specific deviation or the unanticipated occurrence;
(ii) Description of your investigation into the cause of the deviation from the specification or the unanticipated occurrence;
(iii) Evaluation of whether or not the deviation or unanticipated occurrence has resulted in or could lead to a failure to ensure the quality of the dietary supplement or a failure to package and label the dietary supplement as specified in the master manufacturing record;
(iv) Identification of the action(s) taken to correct, and prevent a recurrence of, the deviation or the unanticipated occurrence;
(vii) The signature of the individual(s) designated to perform the quality control operation, who conducted the material review and made the disposition decision, and of each qualified individual who provides information relevant to that material review and disposition decision.