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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21 - Food and Drugs
  4. CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
  6. PART 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
  7. Subpart E - Requirement to Establish a Production and Process Control System

21 CFR Subpart E - Requirement to Establish a Production and Process Control System

  • CFR
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  1. § 111.55 What are the requirements to implement a production and process control system?
  2. § 111.60 What are the design requirements for the production and process control system?
  3. § 111.65 What are the requirements for quality control operations?
  4. § 111.70 What specifications must you establish?
  5. § 111.73 What is your responsibility for determining whether established specifications are met?
  6. § 111.75 What must you do to determine whether specifications are met?
  7. § 111.77 What must you do if established specifications are not met?
  8. § 111.80 What representative samples must you collect?
  9. § 111.83 What are the requirements for reserve samples?
  10. § 111.87 Who conducts a material review and makes a disposition decision?
  11. § 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 § 111.70 is not met?
  12. § 111.95 Under this subpart E, what records must you make and keep?

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