CSQ CERTIFICATION
The CSQ Certification Program and applicable standards were built around ISO/IEC 17067
cGMP Certification for Dietary Supplements: 21 CFR Part 111 Audits
cGMP certification for dietary supplements is independent, third-party verification that your facility manufactures, packages, labels and holds supplements in compliance with the FDA's current Good Manufacturing Practice regulation, 21 CFR Part 111. Kiwa ASI audits your quality system, records, testing and operations so you can prove identity, purity, strength and composition to regulators, retailers and consumers.
- Audited against FDA 21 CFR Part 111, Subparts B–P
- Auditors experienced in supplement manufacturing, packaging & holding
- Nearly a century of food safety expertise
Get a Supplement cGMP Audit Quote
Tell us about your facility and a cGMP specialist will reach out to discuss scope, scheduling and pricing.
What Is cGMP Certification for Dietary Supplements?
cGMP certification for dietary supplements is formal, third-party recognition that a facility manufactures, packages, labels and holds dietary supplements in compliance with the FDA's current Good Manufacturing Practice regulation, 21 CFR Part 111. The regulation, issued in 2007 under the Dietary Supplement Health and Education Act (DSHEA), requires every supplement to be produced in a way that ensures its identity, purity, strength and composition and prevents adulteration or misbranding.
FDA inspects supplement facilities against Part 111 and issues Form 483 observations and warning letters for non-compliance. A Kiwa ASI cGMP audit evaluates your quality system against the same requirements before FDA does, so you can prove compliance to retailers, brand owners and regulators with an independent certificate.
Part 111 goes further than food cGMPs. Unlike human-food cGMPs under 21 CFR Part 117, Part 111 requires a quality control unit, identity testing of every dietary ingredient, written specifications, a Master Manufacturing Record for each product and a Batch Production Record for every batch. Our audit is built around those supplement-specific requirements.
FDA 21 CFR Part 111
Audited directly against the FDA's dietary supplement cGMP regulation, Subparts B through P, not a private retail scheme.
Identity, Purity, Strength & Composition
Verifies the specifications, testing and records that prove each batch is what its label says it is.
Independent Third-Party Verification
An objective audit and certificate from ASI Food Safety, LLC that buyers and brand owners can rely on.
Beyond FDA Compliance
Builds the documented quality system that supports later SQF certification for dietary supplements.
What Does a Dietary Supplement cGMP Audit Cover?
A Kiwa ASI cGMP audit for dietary supplements follows the structure of 21 CFR Part 111 itself. Subparts B through P set the requirements for people, facilities, quality control, records, testing, manufacturing, packaging, holding and complaints. The audit reviews documentation, inspects the facility, interviews staff and traces a batch from components to finished product.
SUBPARTS B–F
Quality System, People & Facility
The foundation of Part 111: who does the work, where it happens and how quality control oversees it.
- Personnel qualifications, training, hygiene and illness controls
- Physical plant, grounds, sanitation, pest control, water and waste
- Equipment and utensils: design, cleaning, calibration and maintenance
- Production and process control system with written procedures
- Quality control unit responsibilities, approvals and rejections
SUBPARTS G–J
Materials, Records & Testing
The specifications, records and laboratory work that prove identity, purity, strength and composition.
- Receipt, quarantine and release of components, packaging and labels
- Identity testing of every dietary ingredient and supplier qualification
- Master Manufacturing Record (MMR) for each unique formulation and batch size
- Batch Production Record (BPR) for every batch, reviewed by quality control
- Laboratory operations, test methods and reserve samples
SUBPARTS K–P
Operations, Distribution & Complaints
How product is made, packaged, held, returned and investigated after it leaves the line.
- Manufacturing operations and contamination and mix-up prevention
- Packaging and labeling operations, label reconciliation and lot identification
- Holding and distributing under conditions that protect the product
- Returned dietary supplements and product complaint investigations
- Record-keeping: records kept 1 year past shelf life, or 2 years past the last distribution
WHO IT'S FOR
Who Needs cGMP Certification for Dietary Supplements?
21 CFR Part 111 applies to anyone who manufactures, packages, labels or holds a dietary supplement for sale in the United States, including own-label distributors who outsource production. Compliance is mandatory; third-party certification is how you prove it.
Certification is typically pursued by contract manufacturers proving control to the brands they serve, brand owners qualifying their supply chain, and quality teams preparing for FDA inspection or retailer review.
Dietary Supplement Manufacturers
Capsules, tablets, powders, softgels, gummies & liquids
Facilities that blend, encapsulate, compress, coat, fill or otherwise manufacture finished dietary supplements under their own or a customer's brand.
Contract Manufacturers & Co-Packers
Producing for other brands
Contract manufacturers that must demonstrate Part 111 compliance to the brand owners and private-label customers they produce for.
Brand Owners & Own-Label Distributors
Responsible for the product they sell
Companies that market supplements made by a contract manufacturer and remain responsible under Part 111 for the products bearing their name.
Packagers & Labelers
Bottling, blister packing & labeling
Operations that receive bulk product for packaging or labeling, where label control, reconciliation and lot identification are audited.
Warehouses & Distributors
Holding & distributing
Facilities that hold or distribute dietary supplements and must protect the product from contamination, deterioration and mix-ups.
Ingredient Suppliers
Serving supplement brands
Suppliers of dietary ingredients and raw materials that want documented GMP controls to support their customers' supplier qualification programs.
Not sure whether Part 111 or Part 117 applies to your operation? Facilities that also make conventional foods, cannabis products or cosmetics may need more than one audit scope. Kiwa ASI confirms your scope before scheduling.
BENEFITS
What Are the Benefits of cGMP Certification for Dietary Supplements?
A cGMP certificate does more than satisfy an auditor. It builds the quality system that protects consumers, keeps FDA inspections uneventful and wins the trust of retailers and brand owners.
Product Quality & Consumer Safety
Written specifications, identity testing and batch records ensure every lot delivers the identity, purity, strength and composition its label promises, reducing contamination, mix-ups and mislabeling.
FDA Inspection Readiness
Part 111 compliance is mandatory in the United States. An independent audit finds gaps before FDA does, lowering the risk of Form 483 observations, warning letters and recalls.
Retailer & Brand-Owner Access
Major retailers, online marketplaces and brand owners increasingly require third-party cGMP verification from the facilities that make their supplements.
Operational Efficiency
Master Manufacturing Records, in-process controls and deviation management standardize production, cut rework and waste, and make scale-up predictable.
Competitive Differentiation
A certificate from an experienced certification body signals credibility to customers, investors and partners who cannot audit you themselves.
A Foundation for GFSI
FDA-ALIGNED
The documented systems Part 111 requires are the base for SQF certification for dietary supplements, making a later GFSI step far less disruptive.
How Do You Prepare for a Dietary Supplement cGMP Audit?
Preparing for a Part 111 audit runs through three phases: building your quality system (steps 1 to 6), the certification audit (steps 7 to 9) and ongoing maintenance (step 10). First-time sites can shorten the timeline with a gap assessment and cGMP training before the official audit.
01
Read 21 CFR Part 111 and Confirm Scope
Work through Subparts B to P and identify which apply to your operation: manufacturing, packaging, labeling, holding or a combination. Kiwa ASI helps confirm your audit scope, including whether Part 117 also applies.
02
Complete a Gap Assessment
Compare current practices against every Part 111 requirement to find gaps in specifications, testing, records, sanitation, personnel practices and quality control oversight.
03
Establish Quality Control and Written Specifications
Define quality control unit responsibilities and write specifications for components, in-process materials, packaging, labels and finished product covering identity, purity, strength, composition and contaminant limits.
04
Build Master Manufacturing Records
Create an MMR for each unique formulation and batch size, with ingredient identities and weights, equipment, process steps, in-process controls, packaging and labeling instructions and quality control checkpoints.
05
Qualify Suppliers and Set Up Testing
Establish identity testing for every dietary ingredient, define testing or certificate-of-analysis reliance for other components, and document laboratory methods, reserve samples and supplier qualification.
06
Train Your Team and Run Batches on Record
Train personnel on cGMP requirements and their responsibilities, then produce batches under complete Batch Production Records so the auditor can see the system working in practice.
07
Schedule Your Audit with Kiwa ASI
Contact Kiwa ASI for a quote and scheduling. We confirm scope and set audit dates that fit your production calendar.
08
Complete the On-Site Audit
An ASI auditor reviews your documentation, inspects the facility and equipment, interviews staff and traces a batch from component receipt through distribution against Part 111.
09
Close Out Corrective Actions
Address any non-conformities with documented corrective actions and root-cause analysis, then submit evidence to Kiwa ASI for review.
10
Receive Your Certificate and Maintain It
Once corrective actions are accepted, your cGMP certificate is issued. Keep records current, investigate complaints and deviations, and schedule your annual re-audit before the certificate expires.
Prepare Your Team with Kiwa ASI cGMP Training
Kiwa ASI's live, instructor-led cGMP V2.0 training builds the quality-system fundamentals a Part 111 audit depends on: documentation and record control, personnel responsibilities, facility and equipment requirements, deviation management, CAPA and data integrity. Sessions are taught by working quality and food safety professionals and built for real-world application.
Current Good Manufacturing Practices
cGMP V2.0: 8-Hour Comprehensive Course
This live, instructor-led course provides a practical understanding of Current Good Manufacturing Practices. It covers quality management systems, documentation control, personnel responsibilities, facility and equipment requirements, deviation management, CAPA and data integrity, and teaches your team to keep the facility audit- and inspection-ready.
8 Contact Hours
Full-Day Session
Live Virtual
Certificate Included
Upcoming Dates — $299 Per Seat
November 4, 2026
🕓 8:30 AM – 4:30 PM CT
💻 Live via Zoom · Full day
Need to train 6+ people? Ask about on-site private training → | US.Info@kiwa-asi.com
Why Choose Kiwa ASI for Dietary Supplement cGMP Certification?
With nearly a century of food safety expertise and the backing of the global Kiwa network across 30+ countries, Kiwa ASI makes Part 111 certification rigorous, clear and efficient.
Certification Body
Experienced, ANAB-Accredited CB
cGMP audits are conducted by ASI Food Safety, LLC, an ANAB-accredited certification body (for its SQF and CSQ programs) with decades of auditing experience. Our dietary supplement cGMP audit is benchmarked to FDA 21 CFR Part 111.
Expertise
Auditors Who Know Part 111
Our auditors bring sector-specific knowledge of supplement manufacturing, from identity testing and Master Manufacturing Records to label control, so findings are practical and audits run efficiently.
One Partner
cGMP Today, SQF Tomorrow
Kiwa ASI also certifies dietary supplement sites to SQF, so the quality system you build for Part 111 can grow into a GFSI-benchmarked certificate without changing certification bodies.
Comprehensive
Integrated Training & Consulting
cGMP training, gap assessments and pre-assessments are offered through ASI Training and Consulting, LLC, kept separate from the certification body to prevent conflicts of interest.
Partnership
Global Kiwa Network
As part of Kiwa, operating in 30+ countries, we provide consistent audit quality and international support wherever your sites are located.
Frequently Asked Questions About cGMP for Dietary Supplements
cGMP certification for dietary supplements is independent, third-party verification that your facility manufactures, packages, labels and holds supplements in compliance with FDA's current Good Manufacturing Practice regulation, 21 CFR Part 111. It covers personnel, facilities, equipment, quality control, specifications and testing, Master Manufacturing Records, Batch Production Records, packaging and labeling, holding, complaints and record-keeping.
Compliance with 21 CFR Part 111 is mandatory for anyone who manufactures, packages, labels or holds dietary supplements for sale in the United States, and FDA inspects facilities against it. Third-party certification is voluntary, but it provides independent evidence of compliance that retailers, brand owners and marketplaces increasingly require.
Part 117 sets the cGMP and preventive-controls requirements for human food. Part 111 is specific to dietary supplements and adds requirements a food cGMP does not, including a quality control unit, identity testing of every dietary ingredient, written specifications, a Master Manufacturing Record for each product and a Batch Production Record for every batch. Facilities that make both conventional foods and supplements may need to be audited against both.
The auditor reviews your written procedures and records, inspects the plant, grounds and equipment, interviews personnel and traces a batch from component receipt through manufacturing, packaging, labeling and distribution. The audit follows Subparts B through P of Part 111, so specifications, identity testing, MMRs, BPRs, laboratory operations, label control, complaint handling and record retention all get reviewed.
Request a quote and confirm your scope with Kiwa ASI, then schedule the audit. An ASI auditor completes the on-site assessment and issues a report. You address any non-conformities with documented corrective actions, and once they are accepted your certificate is issued. The step-by-step guide above walks through preparation in detail.
Most audits take one to three days on site, depending on facility size, product range, number of processes and whether packaging and holding are in scope. Kiwa ASI confirms audit duration when we quote.
Kiwa ASI cGMP certificates are maintained through annual re-audits. Ongoing compliance with Part 111 is required at all times, and FDA may inspect your facility regardless of certification status.
Products made under conditions that do not meet Part 111 are considered adulterated under the Federal Food, Drug, and Cosmetic Act. Consequences can include Form 483 observations, warning letters, product recalls, import refusals, seizures, injunctions and damage to retailer relationships and brand reputation.
Yes. Many retailers, online marketplaces and brand owners require third-party cGMP verification from the facilities that manufacture their supplements. A Kiwa ASI certificate gives them independent assurance without a separate second-party audit, and it is a strong foundation for SQF certification for dietary supplements.
Costs vary based on facility size, complexity, scope and location. Contact Kiwa ASI at 1 (800) 477-0778 or US.Info@kiwa-asi.com for a customized quote.
All consulting services are offered through ASI Training and Consulting, LLC. All activity is conducted separately from our accredited certification body, ASI Food Safety, LLC, in order to safeguard against any conflicts of interest.