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Requirement to Establish a Production and Process Control System | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter B
Part 111
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
Who conducts a material review and makes a disposition decision?
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
Under this subpart E, what records must you make and keep?