Title 21: Food and Drugs
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?
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
§ 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?
Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
Source: 72 FR 34942, June 25, 2007, unless otherwise noted.
