21 CFR 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?
Title 21 published on 2012-04-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
