Part 111 — Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Subpart A — General Provisions
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?
- § 111.90— 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?
- § 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
Subpart I — Production and Process Control System: Requirements for the Batch Production Record
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?