CGA’s dietary supplement cGMP program provides third-party audits and certification against FDA 21 CFR Part 111 for manufacturers, packagers, labelers and holders of dietary supplements.
What is 21 CFR Part 111?
21 CFR Part 111 is the FDA regulation that sets current Good Manufacturing Practice requirements for dietary supplements. It was issued under the authority of the Dietary Supplement Health and Education Act and became fully enforceable for companies of all sizes in 2010. The rule applies to anyone who manufactures, packages, labels or holds a dietary supplement for sale in the United States, including contract manufacturers and companies that only put their own label on someone else’s product.
Part 111 is written as a set of systems rather than a list of prohibited practices. It requires a quality control unit with defined authority, written procedures for every controlled operation, identity testing of incoming dietary ingredients, a master manufacturing record for each formulation and batch size, and a batch production record for every batch actually made. It also requires that all of this be documented in a way a third party can follow after the fact.
Compliance with Part 111, however FDA does not issue or recognise cGMP certificates. What third-party certification does is give buyers, retailers, marketplaces and insurers independent evidence that an operation was assessed against the rule by someone other than the operator.
Who Needs 21 CFR Part 111 Certification
- Dietary supplement manufacturers producing capsules, tablets, softgels, powders, gummies or liquids for the US market.
- Contract manufacturers and co-packers asked by brand customers to evidence Part 111 compliance before a supply agreement is signed.
- Own-label distributors who do not manufacture but carry legal responsibility for their labeled product.
- Packagers, labelers and holders whose operations fall inside the rule even without a production step.
- Ingredient suppliers asked by supplement customers to demonstrate equivalent controls.
- Exporters whose overseas buyers use US cGMP status as a market-entry screen.
If you are unsure whether your activities fall inside the rule, a scoping call resolves it in one conversation. Scope determination is also the first thing CGA assesses in a GMP audit.
21 CFR Part 111 Certification Requirements
Below is the structure of the rule as CGA assesses it. Part 111 is organised into subparts, and the audit follows that organisation so every finding maps directly to the regulation your customers will ask about.
| Subpart | What Is Required | Assessment Requirements |
| A. General Provisions | Scope determination and defined terms applied correctly to your operation | Scope statement, product classification, applicability rationale |
| B. Personnel | Qualified staff, hygiene controls, supervision of each operation | Job descriptions, training records, hygiene SOPs, health reporting |
| C. Physical Plant and Grounds | Facility design that prevents contamination and mix-ups, sanitation program, pest control, water supply | Site plan, zoning and flow, sanitation schedules, pest logs, water testing |
| D. Equipment and Utensils | Suitable equipment, cleaning and maintenance, calibration of instruments, control of automated systems | Equipment register, cleaning logs, calibration certificates, software validation |
| E. Production and Process Control System | A written production and process control system covering every operation | System documentation, SOP index, change control |
| F. Quality Control | A quality control unit with authority to approve or reject components, packaging, labels, in-process material and finished batches | QC charter, authority matrix, disposition records, deviation review |
| G. Components, Packaging and Labels | Identity testing of each dietary ingredient, specifications for all components, supplier qualification, controlled label storage | Identity test results, specifications, COAs, supplier files, label reconciliation |
| H. Master Manufacturing Record | An MMR for each unique formulation and batch size, with specifications and controls at each point | MMR set, approval signatures, version control |
| I. Batch Production Record | A BPR for every batch that follows the MMR and records what actually happened | Completed BPRs, yield reconciliation, deviation entries |
| J. Laboratory Operations | Written laboratory control processes, scientifically valid methods, contract lab oversight | Method validation, lab SOPs, contract lab qualification, raw data |
| K. Manufacturing Operations | Sanitary conditions during production, contamination and cross-contact control, in-process monitoring, rework control | Line clearance records, in-process checks, allergen controls, rework files |
| L. Packaging and Labeling Operations | Correct packaging and labeling, label reconciliation, control of returned or repackaged product | Packaging records, label issue and reconciliation logs |
| M. Holding and Distributing | Controlled storage of components and finished product, distribution records supporting traceability | Storage conditions, inventory control, shipment records |
| N. Returned Dietary Supplements | Identification, quarantine and disposition of returned product, with investigation where a return signals a wider issue | Return logs, quarantine records, investigation reports |
| O. Product Complaints | A written process to receive, review and investigate complaints, with qualified personnel assigned | Complaint register, investigation records, CAPA linkage |
| P. Records and Recordkeeping | Retention of required records and availability for inspection | Retention schedule, storage system, retrieval test, audit trails |
Three Step CGA Part 111 Certification Process
Below is the simple 3-step CGA ISO 22716 GMP Certification process:
Step 1. cGMP Gap Assessment
CGA’s technical team evaluates your operation against Part 111 as it is written and as FDA applies it in inspection.
What is evaluated:
- Scope determination, including whether holding, labeling or packaging activities pull you into the rule
- The quality control unit and whether it holds real authority to reject
- Identity testing practice for incoming dietary ingredients, the most frequently cited failure in the rule
- Master manufacturing records and whether one exists for each formulation and batch size
- Batch production records and whether they reflect what happened rather than what was planned
- Laboratory methods and contract laboratory oversight
- Facility flow, sanitation and cross-contact control
- Records retention and retrievability
Once the evaluation is complete, you receive:
- A gap assessment report written against the subparts, so findings are traceable to the regulation
- A prioritised action plan ordered by audit and enforcement risk
- Early flags on anything that would block certification or draw a 483 observation
Step 2. System Development and Implementation
Most operations arrive with partial systems. This step closes the distance between what exists and what Part 111 requires.
The work covers:
- Building or rewriting SOPs so each controlled operation has a written procedure people actually follow
- Establishing the master manufacturing record set and the batch record structure that flows from it
- Setting up component specifications, supplier qualification and the identity testing program
- Defining quality control unit responsibilities, review points and disposition authority
- Establishing complaint handling, deviation, CAPA and change control processes
- Setting the records retention schedule and confirming records can be retrieved on request
Step 3. Audit & Certification
CGA performs a two-stage GMP audit, consisting of a documentation review and an on-site facility assessment, to confirm the operation meets Part 111 in both paper and practice.
What CGA performs:
- Third-party audit against all applicable subparts of 21 CFR Part 111
- Traceability exercise from incoming dietary ingredient through batch record to distributed lot
- Review of identity test results, specifications and quality control unit dispositions
- Walkthrough of production, packaging, labeling and holding areas
- Employee interviews to confirm procedures are understood at floor level
- Verification that corrective actions from earlier stages were implemented and held
- Issue of the CGA cGMP certificate and verification seal on successful closure
Why Manufacturers Choose CGA
- Auditors who have worked in supplement production – Part 111 findings depend on knowing what a real batch record looks like when it is being filled in correctly and when it is not. CGA assigns auditors with dietary supplement and nutraceutical manufacturing background rather than generalists.
- Findings mapped to the regulation – Every observation cites the subpart it comes from, so your quality team can act on it and your customers can verify it against the rule.
- One audit for several certificates – CGA runs integrated audits that cover cGMP alongside your other programs in a single visit.
- Certification Audit – On-site inspection plus document review by a qualified CGA auditor is carried out next.
- Scheduling that fits production – Audit dates are set around your run schedule, and qualified facilities can access expedited timelines.
Bundle & Save with Multi-Certification Audits
CGA offers combined audit programs so you can certify faster, more cost-effectively:
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Your core audit Dietary Supplement cGMP Certification (21 CFR Part 111)
- Bundle With
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Halal Certification For access to Muslim-majority export markets and for retailers who require it
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Non-GMO Verification For clean-label positioning
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Gluten-Free Certification Commonly requested on supplement labels
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Vegan Certification Relevant where capsule shell and excipient sourcing is a claim
-
IFS certification Where the same site also produces food
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ISO 22716 GMP for cosmetics Where the site runs both supplement and personal care lines
Speak to an Expert
Part 111 is manageable when the system is built properly the first time. If you are considering cGMP certification, the fastest way forward is a focused conversation about your products, your operation and what your buyers are asking for.
The CGA technical team will walk you through:
- Where you stand against Part 111 today
- Which gaps block certification and which can be scheduled
- Expected timelines, audit duration and scope
- Whether an integrated audit makes sense for your certificate set
Reach an expert by calling +1 (813) 906 8113 or by completing the form on this page.
Frequently Asked Questions (FAQs)
No. Compliance with Part 111 is legally required for anyone manufacturing, packaging, labeling or holding dietary supplements for the US market, but FDA does not issue or recognise cGMP certificates. Certification is a third-party assurance mechanism. It exists because buyers, retailers, marketplaces and insurers want independent evidence of compliance rather than a self-declaration.
It is an independent audit of your operation against 21 CFR Part 111, followed by a certificate if the operation meets the requirement. The audit covers your written systems, your records and your practice on the floor. The certificate tells a customer that a qualified third party assessed all three. CGA issues it under the same program discipline as its wider GMP certification scheme.
No. Most facilities begin with gaps, and several begin with almost nothing written down. CGA starts with a structured gap assessment and builds from your actual operation. Where you want implementation support rather than findings alone, that runs through GMP consulting.
A GMP audit is an assessment. It produces findings and a report, and it is often used for supplier qualification or internal readiness. Certification is an audit that leads to a certificate issued under a defined program, with surveillance and a renewal cycle attached. Companies frequently start with an audit and move to certification once buyers begin asking for a certificate.
It depends on readiness. A facility with a working quality system, master manufacturing records and an identity testing program already in place can typically complete the process in four to eight weeks. A facility building the system from scratch should plan for several months, with most of that time spent on implementation rather than on audit. The biggest variable is how quickly gaps get closed.
Four recur across almost every facility CGA assesses:
- No identity testing of incoming dietary ingredients, or reliance on a supplier COA without qualification
- Master manufacturing records missing, incomplete, or not existing for every formulation and batch size
- Batch production records filled in after the fact rather than during production
- A quality control unit that exists on the org chart but has no documented authority to reject
These are the areas CGA addresses first, because they are also the areas FDA cites most often.
Yes. The rule covers manufacturing, packaging, labeling and holding. Own-label distributors and warehouses fall inside its scope even without a production step, and own-label distributors carry responsibility for verifying that their contract manufacturer complies. This is one of the most common scope misunderstandings CGA encounters.
Part 111 is specific to dietary supplements and carries requirements the food and cosmetic rules do not, particularly identity testing of every dietary ingredient and the master manufacturing record. A site producing personal care alongside supplements will usually need ISO 22716 GMP for cosmetics as well, and both can be covered in one audit.
Yes. CGA runs integrated audits covering cGMP alongside halal, gluten-free, Non-GMO and vegan programs at the same site. One auditor visit, one schedule, one set of corrective actions.
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