[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.140]

[Page 245]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
   Subpart F_Production and Process Control System: Requirements for 
                             Quality Control
 
Sec.  111.140  Under this subpart F, what records must you make and keep?

    (a) You must make and keep the records required under this subpart F 
in accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (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
    (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:
    (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;
    (v) Explanation of what you did with the component, dietary 
supplement, packaging, or label;
    (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
    (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.