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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 111Subpart J - Subpart J—Production and Process Control System: Requirements for Laboratory Operations
§ 111.303 - What are the requirements under this subpart J for written procedures?
§ 111.310 - What are the requirements for the laboratory facilities that you use?
§ 111.315 - What are the requirements for laboratory control processes?
§ 111.320 - What requirements apply to laboratory methods for testing and examination?
§ 111.325 - Under this subpart J, what records must you make and keep?
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