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FDA Regulations for Dietary Supplement GMP Compliance

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B–FOOD FOR HUMAN CONSUMPTION

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

§111.103What are the requirements under this subpart F for written procedures?
§111.105What must quality control personnel do?
§111.110What quality control operations are required for laboratory operations associated with the production and process control system?
§111.113What quality control operations are required for a material review and disposition decision?
§111.117What quality control operations are required for equipment, instruments, and controls?
§111.120What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?
§111.123What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?
§111.127What quality control operations are required for packaging and labeling operations?
§111.130What quality control operations are required for returned dietary supplements?
§111.135What quality control operations are required for product complaints?
§111.140Under 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

§111.153What are the requirements under this subpart G for written procedures?
§111.155What requirements apply to components of dietary supplements?
§111.160What requirements apply to packaging and labels received?
§111.165What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)?
§111.170What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?
§111.180Under this subpart G, what records must you make and keep?

Subpart H—PRODUCTION AND PROCESS CONTROL SYSTEM: REQUIREMENTS FOR THE MASTER MANUFACTURING RECORD

§111.205What is the requirement to establish a master manufacturing record?
§111.210What must the master manufacturing record include?

Subpart I—PRODUCTION AND PROCESS CONTROL SYSTEM: REQUIREMENTS FOR THE BATCH PRODUCTION RECORD

§111.255What is the requirement to establish a batch production record?
§111.260What must the batch record include?

Subpart J—PRODUCTION AND PROCESS CONTROL SYSTEM: REQUIREMENTS FOR LABORATORY OPERATIONS

§111.303What are the requirements under this subpart J for written procedures?
§111.310What are the requirements for the laboratory facilities that you use?
§111.315What are the requirements for laboratory control processes?
§111.320What requirements apply to laboratory methods for testing and examination?
§111.325Under this subpart J, what records must you make and keep?

Subpart K—PRODUCTION AND PROCESS CONTROL SYSTEM: REQUIREMENTS FOR MANUFACTURING OPERATIONS

§111.353What are the requirements under this subpart K for written procedures?
§111.355What are the design requirements for manufacturing operations?
§111.360What are the requirements for sanitation?
§111.365What precautions must you take to prevent contamination?
§111.370What requirements apply to rejected dietary supplements?
§111.375Under this subpart K, what records must you make and keep?

Subpart L—PRODUCTION AND PROCESS CONTROL SYSTEM: REQUIREMENTS FOR PACKAGING AND LABELING OPERATIONS

§111.403What are the requirements under this subpart L for written procedures?
§111.410What requirements apply to packaging and labels?
§111.415What requirements apply to filling, assembling, packaging, labeling, and related operations?
§111.420What requirements apply to repackaging and relabeling?
§111.425What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?
§111.430Under this subpart L, what records must you make and keep?

Subpart M—HOLDING AND DISTRIBUTING

§111.453What are the requirements under this subpart for M written procedures?
§111.455What requirements apply to holding components, dietary supplements, packaging, and labels?
§111.460What requirements apply to holding in-process material?
§111.465What requirements apply to holding reserve samples of dietary supplements?
§111.470What requirements apply to distributing dietary supplements?
§111.475Under this subpart M, what records must you make and keep?

Subpart N—RETURNED DIETARY SUPPLEMENTS

§111.503What are the requirements under this subpart N for written procedures?
§111.510What requirements apply when a returned dietary supplement is received?
§111.515When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?
§111.520When may a returned dietary supplement be salvaged?
§111.525What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?
§111.530When must an investigation be conducted of your manufacturing processes and other batches?
§111.535Under this subpart N, what records must you make and keep?

Subpart O—PRODUCT COMPLAINTS

§111.553What are the requirements under this subpart O for written procedures?
§111.560What requirements apply to the review and investigation of a product complaint?
§111.570Under this subpart O, what records must you make and keep?

Subpart P—RECORDS AND RECORDKEEPING

§111.605What requirements apply to the records that you make and keep?
§111.610What records must be made available to FDA?

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