• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-
New Search
Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
 
PART 111CURRENT 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.

-
-