21 CFR 111.140 - Under this subpart F, what records must you make and keep?
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(a) You must make and keep the records required under this subpart F in accordance with subpart P of this part.
(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:
(3) Documentation of any material review and disposition decision and followup. Such documentation must be included in the appropriate batch production record and must include:
(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;
(vi) A scientifically valid reason for any reprocessing of a dietary supplement that is rejected or any treatment or in-process adjustment of a component that is rejected; and
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.