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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter B - Food for Human Consumption |
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Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements |
Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
| § 111.50 - Packaging of iron-containing dietary supplements. |
| Subpart A - General Provisions |
| § 111.1 - Who is subject to this part? |
| § 111.3 - What definitions apply to this part? |
| § 111.5 - Do other statutory provisions and regulations apply? |
| Subpart B - Personnel |
| § 111.8 - What are the requirements under this subpart B for written procedures? |
| § 111.10 - What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices? |
| § 111.12 - What personnel qualification requirements apply? |
| § 111.13 - What supervisor requirements apply? |
| § 111.14 - Under this subpart B, what records must you make and keep? |
| Subpart C - Physical Plant and Grounds |
| § 111.15 - What sanitation requirements apply to your physical plant and grounds? |
| § 111.16 - What are the requirements under this subpart C for written procedures? |
| § 111.20 - What design and construction requirements apply to your physical plant? |
| § 111.23 - Under this subpart C, what records must you make and keep? |
| Subpart D - Equipment and Utensils |
| § 111.25 - What are the requirements under this subpart D for written procedures? |
| § 111.27 - What requirements apply to the equipment and utensils that you use? |
| § 111.30 - What requirements apply to automated, mechanical, or electronic equipment? |
| § 111.35 - Under this subpart D, what records must you make and keep? |
| Subpart E - Requirement to Establish a Production and Process Control System |
| § 111.55 - What are the requirements to implement a production and process control system? |
| § 111.60 - What are the design requirements for the production and process control system? |
| § 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? |
| § 111.77 - What must you do if established specifications are not met? |
| § 111.80 - What representative samples must you collect? |
| § 111.83 - What are the requirements for reserve samples? |
| § 111.87 - Who conducts a material review and makes a disposition decision? |
| § 111.95 - Under this subpart E, what records must you make and keep? |
| Subpart F - Production and Process Control System: Requirements for Quality Control |
| § 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? |
| § 111.120 - 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? |
| § 111.130 - What quality control operations are required for returned dietary supplements? |
| § 111.135 - What quality control operations are required for product complaints? |
| § 111.140 - Under this subpart F, what records must you make and keep? |
| Subpart G - Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement |
| § 111.153 - What are the requirements under this subpart G for written procedures? |
| § 111.155 - What requirements apply to components of dietary supplements? |
| § 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? |
| Subpart H - Production and Process Control System: Requirements for the Master Manufacturing Record |
| § 111.205 - What is the requirement to establish a master manufacturing record? |
| § 111.210 - What must the master manufacturing record include? |
| Subpart I - Production and Process Control System: Requirements for the Batch Production Record |
| § 111.255 - What is the requirement to establish a batch production record? |
| § 111.260 - What must the batch record include? |
| 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? |
| Subpart K - Production and Process Control System: Requirements for Manufacturing Operations |
| § 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? |
| Subpart L - Production and Process Control System: Requirements for Packaging and Labeling Operations |
| § 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? |
| Subpart M - Holding and Distributing |
| § 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? |
| Subpart N - Returned Dietary Supplements |
| § 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? |
| Subpart O - Product Complaints |
| § 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? |
| Subpart P - Records and Recordkeeping |
| § 111.605 - What requirements apply to the records that you make and keep? |
| § 111.610 - What records must be made available to FDA? |