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GxP Compliance for Dietary Supplements
Supporting FDA-Compliant Dietary Supplement Operations
At GxP Auditing and Consulting Services, we help dietary supplement manufacturers, packagers, and distributors align with GxP dietary supplements compliance requirements, especially the FDA’s 21 CFR Part 111. Our consultants bring deep experience in quality assurance, auditing, and regulatory documentation to ensure your operations meet current Good Manufacturing Practice (GMP) standards and GCP expectations where applicable.
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Whether you're launching a new product line or preparing for an upcoming FDA inspection, we offer practical, audit-ready support that fits your workflows, not the other way around.
Why GxP Compliance Matters for Dietary Supplement Companies
The dietary supplements industry continues to grow rapidly, but so does regulatory scrutiny. FDA inspections have become more rigorous, with enforcement focused on data integrity, manufacturing consistency, and product claims.
GxP dietary supplements compliance ensures that your products are manufactured, labeled, and distributed under strict quality control. It also reduces business risks, improves product reliability, and builds long-term consumer trust.
Industries and Product Types We Support
Our consultants have worked with a broad range of dietary supplement businesses, including:
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Contract manufacturers and private labelers
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Herbal, botanical, and nutraceutical supplement producers
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Facilities manufacturing capsules, tablets, powders, and softgels
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Startups launching first-time dietary products in the U.S. market
We understand the practical challenges of maintaining compliance while managing costs, timelines, and supplier quality.
​​GMP Compliance Audits
Scope: Evaluate operations against 21 CFR Part 111 requirements.
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Areas Covered:
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Manufacturing processes (mixing, encapsulation, packaging).
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Raw material receipt, testing, and storage.
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Equipment calibration and maintenance records.
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Sanitation and hygiene practices of personnel and equipment.
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Deliverable: A comprehensive audit report with a list of observations, non-conformances, and corrective action recommendations.
Supplier and Vendor Audits
Scope: Assess the GMP compliance and reliability of suppliers and contract manufacturers.
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Details:
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Review supplier qualification documentation and previous performance data.
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Verify ingredient purity, Certificates of Analysis (COAs), and allergen status.
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Assess traceability systems to ensure material tracking.
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Outcome: Reduce supply chain risks through robust vendor oversight.
Internal Audits and GAP Analysis
Scope: Systematic review of internal processes and documentation.
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Details:
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Check alignment of SOPs with current practices.
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Identify deviations from GMP and company policies.
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Assess the effectiveness of the CAPA system.
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Deliverable: A gap analysis report highlighting areas of improvement, with recommendations for closing identified gaps.
​FDA Mock Audits
Scope: Prepare for FDA inspections through simulated audits.
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Details:
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Focus on product labeling, batch production records, and supplier documentation.
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Check adherence to sanitation, equipment maintenance, and employee training records.
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Conduct interview simulations with key staff.
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Outcome: Avoid Form 483 observations and potential Warning Letters.
Quality System Audits
Scope: Review the company's Quality Management System (QMS).
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Details:
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Assess deviation investigations, change controls, and CAPA processes.
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Review vendor qualification programs and product release procedures.
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Verify documentation for risk management programs such as HACCP or FMEA.
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Outcome: Identify weaknesses in the QMS and ensure continuous improvement.
Labeling and Claims Audits
Scope: Ensure product labels and marketing claims meet FDA and FTC requirements.
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Details:
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Check compliance with 21 CFR Part 101 (food labeling regulations).
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Verify claims such as “gluten-free,” “organic,” or “non-GMO.”
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Ensure scientific substantiation for health-related claims.
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Outcome: Avoid regulatory action and prevent misleading consumers.
GMP Implementation and SOP Development
Scope: Establish GMP-compliant systems from raw material intake to finished product release.
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Details:
Develop SOPs for manufacturing, cleaning, packaging, and warehousing.
Set up a documentation control system for SOPs, records, and logs.
Implement environmental monitoring and hygiene programs.
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Outcome: A seamless and compliant manufacturing operation.
Regulatory Compliance Support
Scope: Provide guidance for compliance with FDA and other international regulations.
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Details:
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Assist with New Dietary Ingredient (NDI) notifications.
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Guide on achieving certifications (e.g., NSF or USP).
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Ensure compliance with export regulations for target markets (e.g., EU, Canada).
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Outcome: Ensure regulatory readiness for domestic and international operations.
​CAPA and Deviation Management
Scope: Improve the CAPA system to prevent recurring issues.
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Details:
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Establish an efficient root cause analysis process.
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Create standardized CAPA templates and procedures.
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Monitor the effectiveness of CAPAs through KPIs.
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Outcome: Minimize deviations and reduce regulatory risks by 15-20%.
Product Recall and Crisis Management
Scope: Develop a compliant product recall procedure.
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Details:
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Set up a recall committee and communication plan.
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Create a system to track products in the supply chain.
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Conduct mock recall exercises to test readiness.
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Outcome: Mitigate risks during product recalls and protect brand reputation.
Vendor Qualification Programs
Scope: Build a system for vendor qualification and re-evaluation.
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Details:
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Develop qualification criteria based on product requirements.
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Create templates for quality agreements and KPIs.
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Establish procedures for ongoing performance monitoring and audits.
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Outcome: Ensure high-quality materials and reduce supply chain disruptions.
Data Integrity Consulting
Scope: Ensure compliance with ALCOA+ principles.
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Details:
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Review data recording processes for accuracy and completeness.
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Audit systems for access control, audit trails, and electronic records.
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Provide remediation plans for identified gaps.
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Outcome: Avoid data integrity violations and FDA penalties.
Process Improvement and Validation Support
Scope: Enhance operational efficiency and validate critical processes.
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Details:
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Assist in process validation (e.g., blending, tablet compression).
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Identify bottlenecks and implement LEAN or Six Sigma improvements.
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Monitor post-validation performance with trending tools.
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Outcome: Achieve consistent product quality and operational efficiency.
Testing and Stability Program Consulting
Scope: Develop and maintain product testing and stability programs.
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Details:
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Define specifications and acceptance criteria for raw and finished products.
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Set up stability studies following ICH guidelines.
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Establish environmental conditions and protocols for stability chambers.
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Outcome: Ensure products meet label claims throughout shelf life.
Change Control and Risk Management
Scope: Build a robust system for managing product and process changes.
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Details:
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Set up change control procedures to document and approve changes.
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Develop HACCP and FMEA programs to manage risks proactively.
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Conduct regular risk assessments and update mitigation plans.
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Outcome: Prevent disruptions and ensure compliant operations.
Training Programs
Scope: Develop and deliver tailored training modules.
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Details:
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Train employees on GMP fundamentals and audit preparedness.
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Provide hands-on training for deviation handling, root cause analysis (RCA), and CAPA.
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Conduct specialized programs for QA personnel on FDA requirements.
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Outcome: Increased employee competence and compliance awareness.
Trusted Auditing & GxP Consulting Support
Every audit we conduct is grounded in years of regulatory experience and best practices. We follow a structured approach tailored to your business stage, whether you’re setting up quality systems, scaling production, or preparing for export.
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Our services are confidential, reliable, and built around FDA, WHO, EMA, and international GMP/GCP expectations. We also offer post-audit guidance and follow-ups to help your team implement changes effectively.
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