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Part 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

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FOOD FOR HUMAN CONSUMPTION - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

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Title 21, Part 111

Title 21, Part 111

Title 21, Part 111

Title 21, Part 111

Title 21, Part 111

Title 21, Part 111

Title 21, Part 111

Title 21, Part 111

Title 21, Part 111

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Title 21, Part 111

Part 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

Description

Official eCFR Link

§111.1 - Who is subject to this part?

§111.10 - What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?

§111.103 - What are the requirements under this subpart F for written procedures?

§111.105 - What must quality control personnel do?

§111.110 - What quality control operations are required for laboratory operations associated with the production and process control system?

§111.113 - What quality control operations are required for a material review and disposition decision?

§111.117 - What quality control operations are required for equipment, instruments, and controls?

§111.12 - What personnel qualification requirements apply?

§111.120 - What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?

§111.123 - What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?

§111.127 - What quality control operations are required for packaging and labeling operations?

§111.13 - What supervisor requirements apply?

§111.130 - What quality control operations are required for returned dietary supplements?

§111.135 - What quality control operations are required for product complaints?

§111.14 - Under this subpart B, what records must you make and keep?

§111.140 - Under this subpart F, what records must you make and keep?

§111.15 - What sanitation requirements apply to your physical plant and grounds?

§111.153 - What are the requirements under this subpart G for written procedures?

§111.155 - What requirements apply to components of dietary supplements?

§111.16 - What are the requirements under this subpart C for written procedures?

§111.160 - What requirements apply to packaging and labels received?

§111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)?

§111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?

§111.180 - Under this subpart G, what records must you make and keep?

§111.20 - What design and construction requirements apply to your physical plant?

§111.205 - What is the requirement to establish a master manufacturing record?

§111.210 - What must the master manufacturing record include?

§111.23 - Under this subpart C, what records must you make and keep?

§111.25 - What are the requirements under this subpart D for written procedures?

§111.255 - What is the requirement to establish a batch production record?

§111.260 - What must the batch record include?

§111.27 - What requirements apply to the equipment and utensils that you use?

§111.3 - What definitions apply to this part?

§111.30 - What requirements apply to automated, mechanical, or electronic equipment?

§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?

§111.35 - Under this subpart D, what records must you make and keep?

§111.353 - What are the requirements under this subpart K for written procedures?

§111.355 - What are the design requirements for manufacturing operations?

§111.360 - What are the requirements for sanitation?

§111.365 - What precautions must you take to prevent contamination?

§111.370 - What requirements apply to rejected dietary supplements?

§111.375 - Under this subpart K, what records must you make and keep?

§111.403 - What are the requirements under this subpart L for written procedures?

§111.410 - What requirements apply to packaging and labels?

§111.415 - What requirements apply to filling, assembling, packaging, labeling, and related operations?

§111.420 - What requirements apply to repackaging and relabeling?

§111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?

§111.430 - Under this subpart L, what records must you make and keep?

§111.453 - What are the requirements under this subpart for M written procedures?

§111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

§111.460 - What requirements apply to holding in-process material?

§111.465 - What requirements apply to holding reserve samples of dietary supplements?

§111.470 - What requirements apply to distributing dietary supplements?

§111.475 - Under this subpart M, what records must you make and keep?

§111.5 - Do other statutory provisions and regulations apply?

§111.503 - What are the requirements under this subpart N for written procedures?

§111.510 - What requirements apply when a returned dietary supplement is received?

§111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

§111.520 - When may a returned dietary supplement be salvaged?

§111.525 - What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?

§111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

§111.535 - Under this subpart N, what records must you make and keep?

§111.55 - What are the requirements to implement a production and process control system?

§111.553 - What are the requirements under this subpart O for written procedures?

§111.560 - What requirements apply to the review and investigation of a product complaint?

§111.570 - Under this subpart O, what records must you make and keep?

§111.60 - What are the design requirements for the production and process control system?

§111.605 - What requirements apply to the records that you make and keep?

§111.610 - What records must be made available to FDA?

§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?