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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i1
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) (Parts 100 to 169)
  4. part 111
    PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
  5. subpart E
    Subpart E—Requirement to Establish a Production and Process Control System

Subpart E. Subpart E—Requirement to Establish a Production and Process Control System

  • § 111.55 - What are the requirements to implement a production and process control system?
  • § 111.60 - What are the design requirements for the production and process control system?
  • § 111.65 - What are the requirements for quality control operations?
  • § 111.70 - What specifications must you establish?
  • § 111.73 - What is your responsibility for determining whether established specifications are met?
  • § 111.75 - What must you do to determine whether specifications are met?
  • § 111.77 - What must you do if established specifications are not met?
  • § 111.80 - What representative samples must you collect?
  • § 111.83 - What are the requirements for reserve samples?
  • § 111.87 -
  • § 111.90 - What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with is not met?
  • § 111.95 - Under this subpart E, what records must you make and keep?
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