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

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 111
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9. Subpart E

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 111.55
  § 111.55 What are the requirements to implement a production and process control system?
• 111.60
  § 111.60 What are the design requirements for the production and process control system?
• 111.65
  § 111.65 What are the requirements for quality control operations?
• 111.70
  § 111.70 What specifications must you establish?
• 111.73
  § 111.73 What is your responsibility for determining whether established specifications are met?
• 111.75
  § 111.75 What must you do to determine whether specifications are met?
• 111.77
  § 111.77 What must you do if established specifications are not met?
• 111.80
  § 111.80 What representative samples must you collect?
• 111.83
  § 111.83 What are the requirements for reserve samples?
• 111.87
  § 111.87 Who conducts a material review and makes a disposition decision?
• 111.90
  § 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?
• 111.95
  § 111.95 Under this subpart E, what records must you make and keep?