Title 21

PART 111 SUBPART j

Subpart J - Production and Process Control System: Requirements for Laboratory Operations

• 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.

21:2.0.1.1.11.10.1.1	SECTION 111.303	111.303 What are the requirements under this subpart J for written procedures
21:2.0.1.1.11.10.1.2	SECTION 111.310	111.310 What are the requirements for the laboratory facilities that you use
21:2.0.1.1.11.10.1.3	SECTION 111.315	111.315 What are the requirements for laboratory control processes
21:2.0.1.1.11.10.1.4	SECTION 111.320	111.320 What requirements apply to laboratory methods for testing and examination
21:2.0.1.1.11.10.1.5	SECTION 111.325	111.325 Under this subpart J, what records must you make and keep

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