2008 CFR Title 21, Volume 2

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 111--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
	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?
	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?
	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?
	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?
	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?
	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?
	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?
	111.205	What is the requirement to establish a master manufacturing record?
	111.210	What must the master manufacturing record include?
	111.255	What is the requirement to establish a batch production record?
	111.260	What must the batch record include?
	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?
	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?
	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?
	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?
	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?
	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?
	111.605	What requirements apply to the records that you make and keep?
	111.610	What records must be made available to FDA?