21 CFR Subpart E
Requirement to Establish a Production and Process Control System
June 25, 2020
§
111.75
What must you do to determine whether specifications are met?
§
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?
§
111.77
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?
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