Supplement Brand Responsibility:
GMP Compliance Starts With You
Outsourcing manufacturing doesn’t mean outsourcing responsibility. Under 21 CFR Part 111, the brand owner is ultimately responsible for ensuring that dietary supplements meet FDA requirements for identity, purity, strength, and composition.1
Vendor Qualification Is Not Optional
You must qualify your contract manufacturer and suppliers—you cannot rely solely on their Certificate of Analysis (COA). FDA regulations require that you verify the reliability of the COA through a risk-based supplier qualification program.2
Qualify Ara Testing Labs for your 3rd party ISO 17025 testing lab.
Vendor qualification methods include:
- Paper audits or onsite inspections
- Testing multiple lots to verify label claims
- Reviewing manufacturer records and batch documentation
- Establishing a Quality Agreement that defines responsibilities 3
What Should a Quality Agreement Include?
According to FDA guidance, a well-written quality agreement should cover 4:
- Scope and purpose of the agreement
- GMP compliance responsibilities
- Quality control and assurance roles
- Complaint handling and recalls
- Change control and process validation
- Financial responsibility for failed release testing
This agreement ensures clarity between the brand and contract manufacturer, especially when issues arise.
Build a Team You Can Trust
GMP compliance is a team effort. To ensure product integrity and regulatory alignment, your brand should build a strong internal and external team.
Your supplement quality team might include:
- R&D Formulator: Develops compliant, effective formulations
- Quality Assurance Team: Sets specifications and reviews testing results
- ISO 17025 Testing Lab: Provides reliable, accredited testing
- Regulatory Affairs Expert: Ensures documentation and compliance
ARA Testing is here to be your trusted lab partner. We help supplement brands meet FDA expectations and maintain product quality from formulation to finished product.
Listen In: Why Brand GMP Responsibility Can’t Be Outsourced
We recently recorded a podcast that dives deeper into a critical truth for supplement brands. In this episode, we explore why supplement brands must take ownership of their compliance strategy—even when working with contract manufacturers. From vendor qualification to quality agreements, your brand is accountable for ensuring every product meets FDA and GMP standards.
This is your chance to gain insight, ask questions, and learn alongside us!
Join us on this journey, and let’s explore the complexities of dietary supplement testing together. Send your questions to [email protected], we want to cover the topics that are important to you
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