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Electronic Code of Federal Regulations

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e-CFR Data is current as of April 17, 2014

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION

PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?


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