Title 21

PART 111 SUBPART E

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

21:2.0.1.1.11.5.1.1SECTION 111.55
   111.55 What are the requirements to implement a production and process control system
21:2.0.1.1.11.5.1.2SECTION 111.60
   111.60 What are the design requirements for the production and process control system
21:2.0.1.1.11.5.1.3SECTION 111.65
   111.65 What are the requirements for quality control operations
21:2.0.1.1.11.5.1.4SECTION 111.70
   111.70 What specifications must you establish
21:2.0.1.1.11.5.1.5SECTION 111.73
   111.73 What is your responsibility for determining whether established specifications are met
21:2.0.1.1.11.5.1.6SECTION 111.75
   111.75 What must you do to determine whether specifications are met
21:2.0.1.1.11.5.1.7SECTION 111.77
   111.77 What must you do if established specifications are not met
21:2.0.1.1.11.5.1.8SECTION 111.80
   111.80 What representative samples must you collect
21:2.0.1.1.11.5.1.9SECTION 111.83
   111.83 What are the requirements for reserve samples
21:2.0.1.1.11.5.1.10SECTION 111.87
   111.87 Who conducts a material review and makes a disposition decision
21:2.0.1.1.11.5.1.11SECTION 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
21:2.0.1.1.11.5.1.12SECTION 111.95
   111.95 Under this subpart E, what records must you make and keep