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FEDERAL · 21 CFR

Part 111 — Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

84 sections · Title 21: Food and Drugs

§ 111.1Who is subject to this part?
§ 111.3What definitions apply to this part?
§ 111.5Do other statutory provisions and regulations apply?
§ 111.8What are the requirements under this subpart B for written procedures?
§ 111.10What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?
§ 111.12What personnel qualification requirements apply?
§ 111.13What supervisor requirements apply?
§ 111.14Under this subpart B, what records must you make and keep?
§ 111.15What sanitation requirements apply to your physical plant and grounds?
§ 111.16What are the requirements under this subpart C for written procedures?
§ 111.20What design and construction requirements apply to your physical plant?
§ 111.23Under this subpart C, what records must you make and keep?
§ 111.25What are the requirements under this subpart D for written procedures?
§ 111.27What requirements apply to the equipment and utensils that you use?
§ 111.30What requirements apply to automated, mechanical, or electronic equipment?
§ 111.35Under this subpart D, what records must you make and keep?
§ 111.55What are the requirements to implement a production and process control system?
§ 111.60What are the design requirements for the production and process control system?
§ 111.65What are the requirements for quality control operations?
§ 111.70What specifications must you establish?
§ 111.73What is your responsibility for determining whether established specifications are met?
§ 111.75What must you do to determine whether specifications are met?
§ 111.77What must you do if established specifications are not met?
§ 111.80What representative samples must you collect?
§ 111.83What are the requirements for reserve samples?
§ 111.87Who conducts a material review and makes a disposition decision?
§ 111.90What 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?
§ 111.95Under this subpart E, what records must you make and keep?
§ 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?
§ 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?
§ 111.205What is the requirement to establish a master manufacturing record?
§ 111.210What must the master manufacturing record include?
§ 111.255What is the requirement to establish a batch production record?
§ 111.260What must the batch record include?
§ 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?
§ 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?
§ 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?
§ 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?
§ 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?
§ 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?
§ 111.605What requirements apply to the records that you make and keep?
§ 111.610What records must be made available to FDA?