CFR /  Title 21  /  Part 111: Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements

Section No.	Description
Section 111.1	What definitions apply to this part?
Section 111.3	Do other statutory provisions and regulations apply?
Section 111.5	What are the requirements under this subpart B for written procedures?
Section 111.8	What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic
Section 111.10	What personnel qualification requirements apply?
Section 111.12	What supervisor requirements apply?
Section 111.13	Under this subpart B, what records must you make and keep?
Section 111.14	What sanitation requirements apply to your physical plant and grounds?
Section 111.15	What are the requirements under this subpart C for written procedures?
Section 111.16	What design and construction requirements apply to your physical plant?
Section 111.20	Under this subpart C, what records must you make and keep?
Section 111.23	What are the requirements under this subpart D for written procedures?
Section 111.25	What requirements apply to the equipment and utensils that you use?
Section 111.27	What requirements apply to automated, mechanical, or electronic equipment?
Section 111.30	Under this subpart D, what records must you make and keep?
Section 111.35	What are the requirements to implement a production and process control system?
Section 111.55	What are the design requirements for the production and process control system?
Section 111.60	What are the requirements for quality control operations?
Section 111.65	What specifications must you establish?
Section 111.70	What is your responsibility for determining whether established specifications are met?
Section 111.73	What must you do to determine whether specifications are met?
Section 111.75	What must you do if established specifications are not met?
Section 111.77	What representative samples must you collect?
Section 111.80	What are the requirements for reserve samples?
Section 111.83	Who conducts a material review and makes a disposition decision?
Section 111.87	What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or
Section 111.90	Under this subpart E, what records must you make and keep?
Section 111.95	What are the requirements under this subpart F for written procedures?
Section 111.103	What must quality control personnel do?
Section 111.105	What quality control operations are required for laboratory operations associated with the production and
Section 111.110	What quality control operations are required for a material review and disposition decision?
Section 111.113	What quality control operations are required for equipment, instruments, and controls?
Section 111.117	What quality control operations are required for components, packaging, and labels before use in the manufacture
Section 111.120	What quality control operations are required for the master manufacturing record, the batch production record,
Section 111.123	What quality control operations are required for packaging and labeling operations?
Section 111.127	What quality control operations are required for returned dietary supplements?
Section 111.130	What quality control operations are required for product complaints?
Section 111.135	Under this subpart F, what records must you make and keep?
Section 111.140	What are the requirements under this subpart G for written procedures?
Section 111.153	What requirements apply to components of dietary supplements?
Section 111.155	What requirements apply to packaging and labels received?
Section 111.160	What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution
Section 111.165	What requirements apply to rejected components, packaging, and labels, and to rejected products that are received
Section 111.170	Under this subpart G, what records must you make and keep?
Section 111.180	What is the requirement to establish a master manufacturing record?
Section 111.205	What must the master manufacturing record include?
Section 111.210	What is the requirement to establish a batch production record?
Section 111.255	What must the batch record include?
Section 111.260	What are the requirements under this subpart J for written procedures?
Section 111.303	What are the requirements for the laboratory facilities that you use?
Section 111.310	What are the requirements for laboratory control processes?
Section 111.315	What requirements apply to laboratory methods for testing and examination?
Section 111.320	Under this subpart J, what records must you make and keep?
Section 111.325	What are the requirements under this subpart K for written procedures?
Section 111.353	What are the design requirements for manufacturing operations?
Section 111.355	What are the requirements for sanitation?
Section 111.360	What precautions must you take to prevent contamination?
Section 111.365	What requirements apply to rejected dietary supplements?
Section 111.370	Under this subpart K, what records must you make and keep?
Section 111.375	What are the requirements under this subpart L for written procedures?
Section 111.403	What requirements apply to packaging and labels?
Section 111.410	What requirements apply to filling, assembling, packaging, labeling, and related operations?
Section 111.415	What requirements apply to repackaging and relabeling?
Section 111.420	What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?
Section 111.425	Under this subpart L, what records must you make and keep?
Section 111.430	What are the requirements under this subpart for M written procedures?
Section 111.453	What requirements apply to holding components, dietary supplements, packaging, and labels?
Section 111.455	What requirements apply to holding in-process material?
Section 111.460	What requirements apply to holding reserve samples of dietary supplements?
Section 111.465	What requirements apply to distributing dietary supplements?
Section 111.470	Under this subpart M, what records must you make and keep?
Section 111.475	What are the requirements under this subpart N for written procedures?
Section 111.503	What requirements apply when a returned dietary supplement is received?
Section 111.510	When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?
Section 111.515	When may a returned dietary supplement be salvaged?
Section 111.520	What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?
Section 111.525	When must an investigation be conducted of your manufacturing processes and other batches?
Section 111.530	Under this subpart N, what records must you make and keep?
Section 111.535	What are the requirements under this subpart O for written procedures?
Section 111.553	What requirements apply to the review and investigation of a product complaint?
Section 111.560	Under this subpart O, what records must you make and keep?
Section 111.570	What requirements apply to the records that you make and keep?
Section 111.605	What records must be made available to FDA?
Section 111.610	Definitions