What are Good Manufacturing Practices (GMP) for dietary supplements?

GMPs ensure that dietary supplements are: • Consistently produced and controlled according to quality standards • Manufactured in a way that prevents contamination and inaccuracies • Produced with appropriate quality control processes in place

Who must comply with GMP regulations?

All companies that manufacture, package, label, or hold dietary supplements for U.S. distribution must comply with FDA GMP regulations under 21 CFR Part 111.

What happens if my facility fails a GMP inspection?

• The FDA may issue Form 483 observations for non-compliance. • You may receive warning letters, face product recalls, or experience import refusals. • Our CAPA development services help you correct issues and regain compliance.

How can I prepare my facility for an FDA GMP inspection?

• Conduct internal GMP audits regularly. • Ensure all SOPs, batch records, and QC documents are up to date. • Train employees on GMP requirements and FDA expectations. • Work with a GMP compliance expert for mock inspections and readiness evaluations.

How often should GMP training be conducted?

• Initial GMP training for new employees is required. • Annual refresher courses are recommended to maintain compliance. • Training should also be updated whenever regulatory changes occur.

How do I get started with your GMP Support Services?

Simply request a demo today! Our team will provide a full walkthrough of how our services can help your business stay compliant, reduce risks, and streamline compliance management.

Dietary Supplement GMP Support (21 CFR 111)

Overview

Service overview

We audit your manufacturing against 21 CFR Part 111, build the SOPs, batch records and QC procedures you need, and prepare your team for FDA inspections.

Product documentation being reviewed for compliance

Why this service matters

GMP rules make sure supplements are produced consistently and to appropriate quality standards.
The FDA enforces GMP to prevent contamination, mislabelling and poor quality control.
Non-compliance can lead to warning letters, recalls and loss of market access.

GMP Readiness Audits & Assessments

We audit your manufacturing processes against 21 CFR Part 111 and identify compliance gaps.

Gap analysis reports highlighting compliance deficiencies
Corrective action recommendations to address identified issues
Pre-inspection audits to prepare for FDA facility inspections

Export-ready goods prepared inside a warehouse — Dietary Supplements
Good Manufacturing Practice (GMP) Compliance Support

GMP Documentation Development & Review

Documentation and record-keeping are essential for GMP compliance, and we help develop, review and maintain the documents you need.

Standard Operating Procedures (SOPs) tailored to your operations
Batch production records and control documentation
Corrective and Preventive Action (CAPA) documentation

Quality Control & Testing Compliance Support

The FDA requires manufacturers to run quality control (QC) procedures, and we help design QC programmes to meet GMP standards.

Raw material and ingredient testing protocols
Finished product testing for potency, purity, and identity
In-process quality control checks during manufacturing

Supplier Qualification & Verification Programmes

Under GMP rules, manufacturers are responsible for qualifying suppliers, and we set up supplier compliance programmes to support ingredient safety.

Ingredient traceability and verification programmes
Documentation review for supplier compliance records
Ongoing monitoring of supplier performance and compliance

GMP Compliance Training for Employees

Employee training is essential for maintaining GMP compliance, and we offer tailored training for everyone involved in supplement manufacturing.

GMP fundamentals and regulatory requirements training
Hands-on training for manufacturing and QC staff
Refresher courses to keep teams updated on regulatory changes

FDA Inspection Preparation & Support

We help you prepare for FDA inspections, with on-site support and post-inspection guidance on any findings.

Pre-inspection mock audits to identify potential compliance risks
Documentation preparation and presentation support
Post-inspection response management and 483 remediation

Ongoing compliance support

Time-Saving
We develop and review GMP documentation with you, cutting the time your team spends on paperwork.
Regulatory Assurance
Gap analysis against 21 CFR Part 111 highlights issues before an FDA inspection does.
Peace of Mind
Stronger quality systems reduce the risk of warning letters, recalls and supply disruption.

What you'll need

GMP support starts from your current documents and testing.

Standard Operating ProceduresYour SOPs as they stand today.
Batch recordsProduction and control documentation.
Testing protocolsRaw material and finished product testing.
Supplier compliance recordsTraceability and verification files for ingredients.

Good Manufacturing Practice (GMP) Compliance Support