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