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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 111
Subpart E - 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 is not met?
§ 111.95 - Under this subpart E, what records must you make and keep?
authority:
21 U.S.C. 321
,
342
,
343
,
371
,
374
,
381
,
393
;
42 U.S.C. 264.
source:
72 FR 34942, June 25, 2007, unless otherwise noted.
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