Title 21

PART 111

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 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.

21:2.0.1.1.11.1SUBPART A
Subpart A - General Provisions
21:2.0.1.1.11.1.1.1SECTION 111.1
   111.1 Who is subject to this part
21:2.0.1.1.11.1.1.2SECTION 111.3
   111.3 What definitions apply to this part
21:2.0.1.1.11.1.1.3SECTION 111.5
   111.5 Do other statutory provisions and regulations apply
21:2.0.1.1.11.2SUBPART B
Subpart B - Personnel
21:2.0.1.1.11.2.1.1SECTION 111.8
   111.8 What are the requirements under this subpart B for written procedures
21:2.0.1.1.11.2.1.2SECTION 111.10
   111.10 What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices
21:2.0.1.1.11.2.1.3SECTION 111.12
   111.12 What personnel qualification requirements apply
21:2.0.1.1.11.2.1.4SECTION 111.13
   111.13 What supervisor requirements apply
21:2.0.1.1.11.2.1.5SECTION 111.14
   111.14 Under this subpart B, what records must you make and keep
21:2.0.1.1.11.3SUBPART C
Subpart C - Physical Plant and Grounds
21:2.0.1.1.11.3.1.1SECTION 111.15
   111.15 What sanitation requirements apply to your physical plant and grounds
21:2.0.1.1.11.3.1.2SECTION 111.16
   111.16 What are the requirements under this subpart C for written procedures
21:2.0.1.1.11.3.1.3SECTION 111.20
   111.20 What design and construction requirements apply to your physical plant
21:2.0.1.1.11.3.1.4SECTION 111.23
   111.23 Under this subpart C, what records must you make and keep
21:2.0.1.1.11.4SUBPART D
Subpart D - Equipment and Utensils
21:2.0.1.1.11.4.1.1SECTION 111.25
   111.25 What are the requirements under this subpart D for written procedures
21:2.0.1.1.11.4.1.2SECTION 111.27
   111.27 What requirements apply to the equipment and utensils that you use
21:2.0.1.1.11.4.1.3SECTION 111.30
   111.30 What requirements apply to automated, mechanical, or electronic equipment
21:2.0.1.1.11.4.1.4SECTION 111.35
   111.35 Under this subpart D, what records must you make and keep
21:2.0.1.1.11.5SUBPART E
Subpart E - Requirement to Establish a Production and Process Control System
21:2.0.1.1.11.5.1.1SECTION 111.55
   111.55 What are the requirements to implement a production and process control system
21:2.0.1.1.11.5.1.2SECTION 111.60
   111.60 What are the design requirements for the production and process control system
21:2.0.1.1.11.5.1.3SECTION 111.65
   111.65 What are the requirements for quality control operations
21:2.0.1.1.11.5.1.4SECTION 111.70
   111.70 What specifications must you establish
21:2.0.1.1.11.5.1.5SECTION 111.73
   111.73 What is your responsibility for determining whether established specifications are met
21:2.0.1.1.11.5.1.6SECTION 111.75
   111.75 What must you do to determine whether specifications are met
21:2.0.1.1.11.5.1.7SECTION 111.77
   111.77 What must you do if established specifications are not met
21:2.0.1.1.11.5.1.8SECTION 111.80
   111.80 What representative samples must you collect
21:2.0.1.1.11.5.1.9SECTION 111.83
   111.83 What are the requirements for reserve samples
21:2.0.1.1.11.5.1.10SECTION 111.87
   111.87 Who conducts a material review and makes a disposition decision
21:2.0.1.1.11.5.1.11SECTION 111.90
   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
21:2.0.1.1.11.5.1.12SECTION 111.95
   111.95 Under this subpart E, what records must you make and keep
21:2.0.1.1.11.6SUBPART F
Subpart F - Production and Process Control System: Requirements for Quality Control
21:2.0.1.1.11.6.1.1SECTION 111.103
   111.103 What are the requirements under this subpart F for written procedures
21:2.0.1.1.11.6.1.2SECTION 111.105
   111.105 What must quality control personnel do
21:2.0.1.1.11.6.1.3SECTION 111.110
   111.110 What quality control operations are required for laboratory operations associated with the production and process control system
21:2.0.1.1.11.6.1.4SECTION 111.113
   111.113 What quality control operations are required for a material review and disposition decision
21:2.0.1.1.11.6.1.5SECTION 111.117
   111.117 What quality control operations are required for equipment, instruments, and controls
21:2.0.1.1.11.6.1.6SECTION 111.120
   111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement
21:2.0.1.1.11.6.1.7SECTION 111.123
   111.123 What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations
21:2.0.1.1.11.6.1.8SECTION 111.127
   111.127 What quality control operations are required for packaging and labeling operations
21:2.0.1.1.11.6.1.9SECTION 111.130
   111.130 What quality control operations are required for returned dietary supplements
21:2.0.1.1.11.6.1.10SECTION 111.135
   111.135 What quality control operations are required for product complaints
21:2.0.1.1.11.6.1.11SECTION 111.140
   111.140 Under this subpart F, what records must you make and keep
21:2.0.1.1.11.7SUBPART G
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
21:2.0.1.1.11.7.1.1SECTION 111.153
   111.153 What are the requirements under this subpart G for written procedures
21:2.0.1.1.11.7.1.2SECTION 111.155
   111.155 What requirements apply to components of dietary supplements
21:2.0.1.1.11.7.1.3SECTION 111.160
   111.160 What requirements apply to packaging and labels received
21:2.0.1.1.11.7.1.4SECTION 111.165
   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)
21:2.0.1.1.11.7.1.5SECTION 111.170
   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
21:2.0.1.1.11.7.1.6SECTION 111.180
   111.180 Under this subpart G, what records must you make and keep
21:2.0.1.1.11.8SUBPART H
Subpart H - Production and Process Control System: Requirements for the Master Manufacturing Record
21:2.0.1.1.11.8.1.1SECTION 111.205
   111.205 What is the requirement to establish a master manufacturing record
21:2.0.1.1.11.8.1.2SECTION 111.210
   111.210 What must the master manufacturing record include
21:2.0.1.1.11.9SUBPART I
Subpart I - Production and Process Control System: Requirements for the Batch Production Record
21:2.0.1.1.11.9.1.1SECTION 111.255
   111.255 What is the requirement to establish a batch production record
21:2.0.1.1.11.9.1.2SECTION 111.260
   111.260 What must the batch record include
21:2.0.1.1.11.10SUBPART J
Subpart J - Production and Process Control System: Requirements for Laboratory Operations
21:2.0.1.1.11.10.1.1SECTION 111.303
   111.303 What are the requirements under this subpart J for written procedures
21:2.0.1.1.11.10.1.2SECTION 111.310
   111.310 What are the requirements for the laboratory facilities that you use
21:2.0.1.1.11.10.1.3SECTION 111.315
   111.315 What are the requirements for laboratory control processes
21:2.0.1.1.11.10.1.4SECTION 111.320
   111.320 What requirements apply to laboratory methods for testing and examination
21:2.0.1.1.11.10.1.5SECTION 111.325
   111.325 Under this subpart J, what records must you make and keep
21:2.0.1.1.11.11SUBPART K
Subpart K - Production and Process Control System: Requirements for Manufacturing Operations
21:2.0.1.1.11.11.1.1SECTION 111.353
   111.353 What are the requirements under this subpart K for written procedures
21:2.0.1.1.11.11.1.2SECTION 111.355
   111.355 What are the design requirements for manufacturing operations
21:2.0.1.1.11.11.1.3SECTION 111.360
   111.360 What are the requirements for sanitation
21:2.0.1.1.11.11.1.4SECTION 111.365
   111.365 What precautions must you take to prevent contamination
21:2.0.1.1.11.11.1.5SECTION 111.370
   111.370 What requirements apply to rejected dietary supplements
21:2.0.1.1.11.11.1.6SECTION 111.375
   111.375 Under this subpart K, what records must you make and keep
21:2.0.1.1.11.12SUBPART L
Subpart L - Production and Process Control System: Requirements for Packaging and Labeling Operations
21:2.0.1.1.11.12.1.1SECTION 111.403
   111.403 What are the requirements under this subpart L for written procedures
21:2.0.1.1.11.12.1.2SECTION 111.410
   111.410 What requirements apply to packaging and labels
21:2.0.1.1.11.12.1.3SECTION 111.415
   111.415 What requirements apply to filling, assembling, packaging, labeling, and related operations
21:2.0.1.1.11.12.1.4SECTION 111.420
   111.420 What requirements apply to repackaging and relabeling
21:2.0.1.1.11.12.1.5SECTION 111.425
   111.425 What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution
21:2.0.1.1.11.12.1.6SECTION 111.430
   111.430 Under this subpart L, what records must you make and keep
21:2.0.1.1.11.13SUBPART M
Subpart M - Holding and Distributing
21:2.0.1.1.11.13.1.1SECTION 111.453
   111.453 What are the requirements under this subpart for M written procedures
21:2.0.1.1.11.13.1.2SECTION 111.455
   111.455 What requirements apply to holding components, dietary supplements, packaging, and labels
21:2.0.1.1.11.13.1.3SECTION 111.460
   111.460 What requirements apply to holding in-process material
21:2.0.1.1.11.13.1.4SECTION 111.465
   111.465 What requirements apply to holding reserve samples of dietary supplements
21:2.0.1.1.11.13.1.5SECTION 111.470
   111.470 What requirements apply to distributing dietary supplements
21:2.0.1.1.11.13.1.6SECTION 111.475
   111.475 Under this subpart M, what records must you make and keep
21:2.0.1.1.11.14SUBPART N
Subpart N - Returned Dietary Supplements
21:2.0.1.1.11.14.1.1SECTION 111.503
   111.503 What are the requirements under this subpart N for written procedures
21:2.0.1.1.11.14.1.2SECTION 111.510
   111.510 What requirements apply when a returned dietary supplement is received
21:2.0.1.1.11.14.1.3SECTION 111.515
   111.515 When must a returned dietary supplement be destroyed, or otherwise suitably disposed of
21:2.0.1.1.11.14.1.4SECTION 111.520
   111.520 When may a returned dietary supplement be salvaged
21:2.0.1.1.11.14.1.5SECTION 111.525
   111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing
21:2.0.1.1.11.14.1.6SECTION 111.530
   111.530 When must an investigation be conducted of your manufacturing processes and other batches
21:2.0.1.1.11.14.1.7SECTION 111.535
   111.535 Under this subpart N, what records must you make and keep
21:2.0.1.1.11.15SUBPART O
Subpart O - Product Complaints
21:2.0.1.1.11.15.1.1SECTION 111.553
   111.553 What are the requirements under this subpart O for written procedures
21:2.0.1.1.11.15.1.2SECTION 111.560
   111.560 What requirements apply to the review and investigation of a product complaint
21:2.0.1.1.11.15.1.3SECTION 111.570
   111.570 Under this subpart O, what records must you make and keep
21:2.0.1.1.11.16SUBPART P
Subpart P - Records and Recordkeeping
21:2.0.1.1.11.16.1.1SECTION 111.605
   111.605 What requirements apply to the records that you make and keep
21:2.0.1.1.11.16.1.2SECTION 111.610
   111.610 What records must be made available to FDA