Title 21

PART 111 SUBPART E

Subpart E - Requirement to Establish a Production and Process Control System

• 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
• 72 FR 34942, June 25, 2007, unless otherwise noted.

21:2.0.1.1.11.5.1.1	SECTION 111.55	111.55 What are the requirements to implement a production and process control system
21:2.0.1.1.11.5.1.2	SECTION 111.60	111.60 What are the design requirements for the production and process control system
21:2.0.1.1.11.5.1.3	SECTION 111.65	111.65 What are the requirements for quality control operations
21:2.0.1.1.11.5.1.4	SECTION 111.70	111.70 What specifications must you establish
21:2.0.1.1.11.5.1.5	SECTION 111.73	111.73 What is your responsibility for determining whether established specifications are met
21:2.0.1.1.11.5.1.6	SECTION 111.75	111.75 What must you do to determine whether specifications are met
21:2.0.1.1.11.5.1.7	SECTION 111.77	111.77 What must you do if established specifications are not met
21:2.0.1.1.11.5.1.8	SECTION 111.80	111.80 What representative samples must you collect
21:2.0.1.1.11.5.1.9	SECTION 111.83	111.83 What are the requirements for reserve samples
21:2.0.1.1.11.5.1.10	SECTION 111.87	111.87 Who conducts a material review and makes a disposition decision
21:2.0.1.1.11.5.1.11	SECTION 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
21:2.0.1.1.11.5.1.12	SECTION 111.95	111.95 Under this subpart E, what records must you make and keep

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