[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: 21CFR111.73] [Page 238] 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 E_Requirement to Establish a Production and Process Control System Sec. 111.73 What is your responsibility for determining whether established specifications are met? You must determine whether the specifications you establish under Sec. 111.70 are met.