[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: 21CFR111.103] [Page 242] 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. 111.103 What are the requirements under this subpart F for written procedures? You must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing.