Natural Health Products

We bring extensive experience and expertise to get your natural health product to market quickly, efficiently and compliantly. Do you need a license to sell vitamins and supplements? Yes. You need product licenses and activity licenses. Our roots originate in the Natural Health Products industry. Over the years, we have developed robust insights and processes for supporting clients with Product License Applications and Compliance with Health Canada regulations. We are often the firm of choice when issues arise between brand owners and the regulators often serving as a liaison between the company, their legal advisors and the regulator.

A comprehensive  quality management system (QMS) is crucial for maintaining high standards in the manufacturing, packaging, labeling, and/or importing of natural health products or dietary supplements. By designing a robust quality management system, companies can ensure compliance with regulatory expectations, improve their overall quality assurance processes and ensure long-term viability in the marketplace. One essential aspect of this system includes conducting regular GMP audit assessments to verify adherence to Good Manufacturing Practices. For businesses wondering what license you need to sell supplements, a NNHPD-issued Site License is required. It is important to note that a robust quality management system is required before a license is issued. Our comprehensive GMP audit services ensure your firm complies with the government’s expectations. These quality control services help identify potential areas for improvement and ensure that all regulatory standards are consistently met, thereby safeguarding product quality and consumer safety, and business longevity. The reason why we are one of the most trusted GMP audit companies is due to our certified GMP auditors heavily review and examine your business to ensure you are adhering to regulatory requirements.

GMP Audits for the Natural Health Products/Dietary Supplements

Audit Criteria for Natural Health Products (Canada) and Dietary Supplements (USA)

The regulatory requirements for natural health products (NHPs) in Canada and dietary supplements in the United States are increasingly aligned with pharmaceutical GMP principles, demanding robust quality systems, supplier controls, and traceable manufacturing practices.

At MCS Associates, we conduct independent, third-party GMP audits tailored to Canadian and U.S. regulatory frameworks, ensuring your products are safe, compliant, and market-ready across North America.

Primary Regulatory Reference:

• Health Canada GMP Requirements for NHPs – Natural Health Products Regulations (SOR/2003-196)
• Good Manufacturing Practices for NHPs (GUI-0006)
• Site Licensing Requirements and Guidance Document

Key Audit Criteria:

1. Site Licensing Compliance
   • Evaluation of facilities, SOPs, and quality systems required to obtain or maintain an NHP Site Licence.
2. Premises and Equipment Controls
   • Cleanliness, design, and segregation practices to prevent cross-contamination.
3. Personnel Qualifications and Training
   • Competency and documented training of individuals involved in production, QC, and QA.
4. Sanitation and Hygiene Programs
   • Cleaning records, pest control logs, and material handling hygiene.
5. Standard Operating Procedures (SOPs)
   • Review of core GMP SOPs including complaint handling, deviation reporting, CAPA, etc.
6. Batch Records and Traceability
   • Full documentation from raw material intake to finished product release.
7. Product Testing and Stability
   • Identity and purity testing per label claims and validation of shelf-life.
8. Recall and Complaint Handling
   • Effective systems for recall traceability and post-market surveillance.

Primary Regulatory Reference:

• U.S. FDA 21 CFR Part 111 – Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

Key Audit Criteria:

1. Master Manufacturing Records (MMRs) and Batch Production Records (BPRs)
   • Verification of complete, accurate, and compliant recordkeeping.
2. Supplier Qualification and Ingredient Verification
   • Review of supplier risk assessments and Certificates of Analysis (CoAs) for each lot.
3. Identity Testing of Raw Materials
   • Compliance with mandatory identity testing for all ingredients (per 21 CFR §111.75).
4. Quality Control Operations
   • Audit of independent QC unit responsibilities, lab testing, and product release procedures.
5. Personnel and Facility Controls
   • Qualifications, GMP training records, and facility maintenance documentation.
6. Packaging, Labeling, and Storage Practices
   • Label claim substantiation and allergen control procedures.
7. Product Complaints, Adverse Event Reporting & CAPA
   • Systems for evaluating and responding to product issues in the market.
8. Audit Trail and Records Retention
   • Electronic and paper records traceability per 21 CFR Part 111 Subpart P.

Whether regulated as NHPs in Canada or dietary supplements in the U.S., these product categories face growing scrutiny from regulators, retailers, and consumers. Consistent, third-party GMP audits ensure:

• Market access and retailer acceptance
• Protection against product recalls or import refusals
• Readiness for Health Canada or FDA inspections
• Compliance with evolving global quality expectations

MCS Associates is a recognized partner to contract manufacturers, brand holders, distributors, and ingredient suppliers. Our independent audits provide the evidence and insight needed to maintain compliance and protect brand reputation.

• Experienced in Health Canada Site Licensing and FDA 483 remediation
  
• Vendor and contract manufacturer audits across Canada, U.S., India, China, and EU
  
• Actionable, risk-ranked audit reports and CAPA recommendations
• Custom audit programs tailored to your product type and market access strategy

Contact MCS Associates today to schedule a third-party NHP or dietary supplement audit aligned with Canadian and U.S. regulatory standards.