REJIMUS is a preeminent regulatory consulting firm that helps companies globally in the Homeopathic, Food and Dietary Supplement industries improve and ensure the overall quality of their products meanwhile complying with the applicable GMP regulations including CFR 21 Part 111, Part 110 and/or Part 101.
We specialize in FDA Compliance Consulting, Quality Development Services, Social Media Monitoring, Due Diligence, NDI and GRAS Notifications and Business Resource Services. Whether you are a start-up company focused on getting your first product to market and need to implement a quality system from scratch or you are a large established organization that needs to optimize and reduce risks and operating costs in regulatory and quality, we can enable you to achieve your goals efficiently.
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
§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?
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?
§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?
§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?
Business Models Supported
- Contract manufacturer, Toll manufacturer, Private Label Manufacturer, Co-packer
- Retailers (online and storefront)
- Own-label Distributors, Contract Storage, Contract Distributors
- Direct Response and Online Marketers (for MLM’s, Network Marketers, Affiliates, IBO’s, Independent Distributor, etc.)
- Ingredient Manufacturers and Suppliers
- Specialty Events Promotion, Event Management and Marketing/Advertising Companies in the Food, Dietary, Bodybuilding and Sport Nutrition sectors.
Customized Support for 21 CFR Part 111
- Immediate regulatory support for FTC Actions, FDA Inspections, Form 483′s and Warning Letter responses
- GMP compliance planning and training
- Strategic budgeting and guidance for restructuring of quality and regulatory operations
- Writing, review and/or optimizing standard operating protocols (SOPs) and specifications for raw materials and finished products
- Technical and analytical data review data, testing procedures, study protocols, or close-out investigations
- Support for managing products complaints and adverse events
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