Title 21, Part 111 — Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
84 sections
Section 111.1
Who is subject to this part?
Section 111.3
What definitions apply to this part?
Section 111.5
Do other statutory provisions and regulations apply?
Section 111.8
What are the requirements under this subpart B for written procedures?
Section 111.10
What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?
Section 111.12
What personnel qualification requirements apply?
Section 111.13
What supervisor requirements apply?
Section 111.14
Under this subpart B, what records must you make and keep?
Section 111.15
What sanitation requirements apply to your physical plant and grounds?
Section 111.16
What are the requirements under this subpart C for written procedures?
Section 111.20
What design and construction requirements apply to your physical plant?
Section 111.23
Under this subpart C, what records must you make and keep?
Section 111.25
What are the requirements under this subpart D for written procedures?
Section 111.27
What requirements apply to the equipment and utensils that you use?
Section 111.30
What requirements apply to automated, mechanical, or electronic equipment?
Section 111.35
Under this subpart D, what records must you make and keep?
Section 111.55
What are the requirements to implement a production and process control system?
Section 111.60
What are the design requirements for the production and process control system?
Section 111.65
What are the requirements for quality control operations?
Section 111.70
What specifications must you establish?
Section 111.73
What is your responsibility for determining whether established specifications are met?
Section 111.75
What must you do to determine whether specifications are met?
Section 111.77
What must you do if established specifications are not met?
Section 111.80
What representative samples must you collect?
Section 111.83
What are the requirements for reserve samples?
Section 111.87
Who conducts a material review and makes a disposition decision?
Section 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?
Section 111.95
Under this subpart E, what records must you make and keep?
Section 111.103
What are the requirements under this subpart F for written procedures?
Section 111.105
What must quality control personnel do?
Section 111.110
What quality control operations are required for laboratory operations associated with the production and process control system?
Section 111.113
What quality control operations are required for a material review and disposition decision?
Section 111.117
What quality control operations are required for equipment, instruments, and controls?
Section 111.120
What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
Section 111.123
What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
Section 111.127
What quality control operations are required for packaging and labeling operations?
Section 111.130
What quality control operations are required for returned dietary supplements?
Section 111.135
What quality control operations are required for product complaints?
Section 111.140
Under this subpart F, what records must you make and keep?
Section 111.153
What are the requirements under this subpart G for written procedures?
Section 111.155
What requirements apply to components of dietary supplements?
Section 111.160
What requirements apply to packaging and labels received?
Section 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)?
Section 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?
Section 111.180
Under this subpart G, what records must you make and keep?
Section 111.205
What is the requirement to establish a master manufacturing record?
Section 111.210
What must the master manufacturing record include?
Section 111.255
What is the requirement to establish a batch production record?
Section 111.260
What must the batch record include?
Section 111.303
What are the requirements under this subpart J for written procedures?
Section 111.310
What are the requirements for the laboratory facilities that you use?
Section 111.315
What are the requirements for laboratory control processes?
Section 111.320
What requirements apply to laboratory methods for testing and examination?
Section 111.325
Under this subpart J, what records must you make and keep?
Section 111.353
What are the requirements under this subpart K for written procedures?
Section 111.355
What are the design requirements for manufacturing operations?
Section 111.360
What are the requirements for sanitation?
Section 111.365
What precautions must you take to prevent contamination?
Section 111.370
What requirements apply to rejected dietary supplements?
Section 111.375
Under this subpart K, what records must you make and keep?
Section 111.403
What are the requirements under this subpart L for written procedures?
Section 111.410
What requirements apply to packaging and labels?
Section 111.415
What requirements apply to filling, assembling, packaging, labeling, and related operations?
Section 111.420
What requirements apply to repackaging and relabeling?
Section 111.425
What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?
Section 111.430
Under this subpart L, what records must you make and keep?
Section 111.453
What are the requirements under this subpart for M written procedures?
Section 111.455
What requirements apply to holding components, dietary supplements, packaging, and labels?
Section 111.460
What requirements apply to holding in-process material?
Section 111.465
What requirements apply to holding reserve samples of dietary supplements?
Section 111.470
What requirements apply to distributing dietary supplements?
Section 111.475
Under this subpart M, what records must you make and keep?
Section 111.503
What are the requirements under this subpart N for written procedures?
Section 111.510
What requirements apply when a returned dietary supplement is received?
Section 111.515
When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?
Section 111.520
When may a returned dietary supplement be salvaged?
Section 111.525
What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?
Section 111.530
When must an investigation be conducted of your manufacturing processes and other batches?
Section 111.535
Under this subpart N, what records must you make and keep?
Section 111.553
What are the requirements under this subpart O for written procedures?
Section 111.560
What requirements apply to the review and investigation of a product complaint?
Section 111.570
Under this subpart O, what records must you make and keep?
Section 111.605
What requirements apply to the records that you make and keep?
Section 111.610
What records must be made available to FDA?