Dietary Supplements - 21 CFR 111
PART 111 – CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR 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?
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?
111.75 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 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 the 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?
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 Bath 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?
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, and 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?
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?