cGMP Consultant for Food and Supplement Manufacturers
Our cGMP consultants and former auditors build your current Good Manufacturing Practice program, keep it aligned with FDA regulations, and prepare you for inspection so an investigator finds a clean, controlled operation.
- Programs built to 21 CFR Part 117 for food and Part 111 for supplements
- FDA inspection preparation and Form 483 response support
- Guidance from a team that has run more than 500 audits
A 30-minute call with a cGMP expert. No cost and no obligation.
- 500+
- Facilities audited by our lead consultant
- 2
- Core rules we build to: Part 117 and Part 111
- 15
- Days for FDA Form 483 Response
- 30
- Min free consultation to get started
What is cGMP, and what does the "c" mean?
cGMP stands for current Good Manufacturing Practice. It is the set of requirements the FDA enforces to make sure a facility consistently produces safe, properly labeled product. The everyday basics are the same as GMP: hygiene, sanitation, equipment, process control, and records.
The "c" is the part that catches manufacturers out. Current means you have to keep your systems, methods, and technology up to date, not frozen at whatever met the rule years ago. The FDA judges you against current expectations at the time of inspection.
For food, the requirements live in 21 CFR Part 117, Subpart B, which replaced the older Part 110 under FSMA. Dietary supplement and nutraceutical makers follow 21 CFR Part 111, which adds identity, purity, strength, and composition testing. We build to the rule that governs your product.
New to this?If you want the plain-language overview of Good Manufacturing Practices first, start with our GMP consulting page. This page covers the current, FDA-facing side of cGMP.
The cGMP rule for your product
The regulation depends on what you make. We confirm which one governs your facility and build your program to it.
| WHAT YOU MAKE | GOVERNING RULE | WHAT IT ADDs |
|---|---|---|
| Food and beverage | 21 CFR Part 117 | cGMP in Subpart B, plus preventive controls under FSMA |
| Dietary supplements and nutraceuticals | 21 CFR Part 111 | Identity, purity, strength, and composition testing |
| Bottled water and beverage | 21 CFR Parts 117 and 129 (bottled water), Part 120 (juice) | Food cGMP plus process-specific controls |
| Cannabis edibles | Food-grade cGMP | Food GMP practices applied to meet state edible requirements |
Cosmetics and over-the-counter drug products fall under separate FDA rules. We focus on food, beverage, and dietary supplement cGMP, and will tell you plainly if your product sits outside that scope.
The systems an FDA investigator will check
cGMP is more than a clean floor. It is a documented system that proves control day after day. These are the areas we build and keep current.
Personnel and hygiene
Health, clothing, hand-washing, and training for everyone on the floor.
Sanitation and SSOPs
Master sanitation schedule, cleaning validation, and pest control.
Facility and equipment
Design, maintenance, and calibration that prevent contamination.
Process controls
Monitoring, in-process checks, and control of production steps.
Records and documentation
Complete, current, and retrievable records that prove control.
CAPA
Corrective and preventive actions that close problems and stop repeats.
Testing and verification
Product and environmental testing, including Part 111 supplement testing.
Supplier controls
Approval, specifications, and incoming material verification.
Allergen and label control
Segregation, labeling, and checks that protect the consumer.
Ready for the inspection, and for what comes after
A cGMP program is tested when an FDA investigator walks in. We prepare you for the inspection and stand with you if observations follow.
Inspection readiness
Mock inspection, records review, and staff coaching so your team knows exactly what to show, what to say, and where every critical record lives before the FDA arrives.
- BEFORE
Form 483 response
If an investigator issues a Form 483 with inspectional observations, we help you draft a corrective action response inside the 15 business day window the FDA expects.
- DURING AND AFTER
Warning letter remediation
If observations escalate to a warning letter, we build and document the remediation plan that brings your facility back into compliance.
- ESCALATION
How we get your facility cGMP compliant
Five phases used by hundreds of manufacturers. Most sites reach inspection readiness in weeks, not months.
1. Gap assessment
We review your facility and records against the cGMP rule that applies, then map every gap and how to close it.
- Facility walk-through and document review
- Findings measured against Part 117 or Part 111
2. Documentation and CAPA
We write the SOPs, sanitation programs, and records the rule requires, and set up a CAPA system that holds.
- SOPs, SSOPs, and master sanitation schedule
- CAPA, supplier approval, and testing programs
3. Implementation and training
We put the system to work on the floor and train your team on their responsibilities.
- Role-based cGMP training with records
- Records live on paper or in the app
4. Mock inspection
We run a mock FDA inspection, surface findings, and close them before a real investigator can.
- Mock inspection with a findings list
- Corrective actions verified
5. Ongoing compliance
Current means current. We keep your program aligned as products, processes, and regulations change.
- Periodic reviews and updates
- Support for inspections and any Form 483
Choose the level of support you need
Assess your gaps, build the full program, or keep your compliance current. Every engagement begins with a free consultation.
cGMP Gap and 483 Readiness
Start here. Find out where you stand against the rule and how you would fare in an inspection.
- Facility and records review
- Gap report against Part 117 or Part 111
- Inspection readiness check
- Prioritized action plan
cGMP Program Build
Full build. A complete, inspection-ready cGMP program built and implemented with your team.
- Everything in the gap assessment
- SOPs, sanitation, and CAPA system
- Testing and supplier programs
- Staff training and a mock inspection
Ongoing cGMP Support
Stay current. Keep your program current and your team ready for any inspection.
- Periodic reviews and updates
- Support for new products and lines
- Form 483 and warning letter support
- Records maintained in the app
Meet the lead of our cGMP team
"I have audited more than 500 manufacturers. I know what an FDA investigator looks for on a cGMP inspection, and I build your program so the observations do not come."
Dave Seddon, MBA, RDN, LDN, CFSO
Co-founder of FoodReady and a finalist for SQF Auditor of the Year named by the SQF Institute.
- 500+ audits
- GMP and SQF expertise
- FDA and USDA experience
Keep your cGMP records inspection-ready every day
Consulting delivers the program. The FoodReady app helps your team keep it current: SOPs, sanitation logs, training records, CAPA, and traceability in one place, retrievable in seconds when an investigator asks. It is optional and included with enterprise and manufacturing subscriptions.
- Digital SOPs and logs -Sanitation and process records on mobile.
- CAPA tracking -Log, assign, and close corrective actions.
- Training records -Tracked completion for every employee.
- Searchable archive -Any record found in seconds during inspection.
Dashboard
What manufacturers say about working with us
"Food safety as a mandatory path has only become important in the last 10-15 years in the food industry. Nowadays, the FDA, USDA, SQF, and consumers no longer care if the food quality is good if it cannot be proven food-safe. What attracted Eurobake to FoodReady software is that FoodReady started with food safety and food traceability as its core. And because of this construct, it can easily be bolted on to accounting or manufacturing modules without corrupting or overcomplicating the data gathering process"
"FoodReady food safety software and SQF / GMP expert QA Manager Consultants helped us prepare for and develop the required haccp plans and SOPs and recall plan and checklists and batch monitoring for our future GMP certification audit which we passed. This has allowed us to expand our business relationship with a national grocery chain. We can’t thank FoodReady enough for the wonderful assistance they provided!"
Frequently Asked Questions
What is a cGMP Consultant?
A cGMP consultant helps a manufacturer meet current Good Manufacturing Practice requirements enforced by the FDA. They assess your facility, write SOPs and records, build a CAPA system, train staff, and prepare you for inspection under 21 CFR Part 117 for food or Part 111 for dietary supplements.
What is the difference between GMP and cGMP?
They describe the same practices. cGMP adds "current," which means the FDA expects up-to-date methods and technology, not systems frozen at an older standard. For food, the current requirements are in 21 CFR Part 117, Subpart B. If you want the general overview first, see our GMP consulting page.
Is cGMP compliance mandatory?
Yes. cGMP is a legal requirement enforced by the FDA. Food facilities follow 21 CFR Part 117 and dietary supplement makers follow 21 CFR Part 111. The FDA verifies compliance during inspection, and gaps can lead to a Form 483, a warning letter, or a recall.
What happens if the FDA issues a Form 483?
A Form 483 lists inspectional observations, the conditions an investigator believes may violate the rules. It is not a final decision, but you should respond with a corrective action plan within 15 business days so the FDA considers it before deciding on further action. We help you write and evidence that response, and remediate if it escalates to a warning letter.
How can a cGMP consultant help with audit preparation?
A cGMP consultant can conduct gap assessments, review documentation, train employees, and implement corrective actions to ensure compliance with GMP standards and a successful audit outcome.
Do you cover dietary supplements under Part 111?
Yes. Dietary supplement and nutraceutical manufacturing follows 21 CFR Part 111, which adds identity, purity, strength, and composition testing on top of the general cGMP basics. We build Part 111 programs, including the specification and testing controls the rule requires.
Can cGMP consultants help integrate cGMP standards into broader food safety programs like SQF or BRC?
Yes, cGMP consultants can help integrate cGMP standards into broader food safety certifications like SQF, BRCGS, or GFSI to streamline compliance efforts and enhance your overall food safety management system.
What are the key components of a cGMP program that a consultant can help develop?
A cGMP consultant can assist in developing essential components such as sanitation practices, documentation control, training programs, production process monitoring, and corrective action procedures to ensure compliance with regulatory standards.
Can a cGMP consultant assist with maintaining ongoing compliance after certification?
Yes, cGMP consultants provide ongoing support by conducting periodic reviews, updating programs to meet changing regulations, and ensuring that your practices remain compliant and audit-ready.
How long does it take, and what does it cost?
Most facilities reach inspection readiness in weeks, depending on size and existing documentation. Cost depends on your size, current program maturity, and the applicable rule. After a free consultation we provide a clear, fixed-scope quote with no surprise fees.
Get your facility cGMP ready
Book a free consultation. We will look at your product and facility and tell you exactly what your cGMP program needs to pass inspection.