GRMA Product Integrity Program – Dietary Supplements

The Global Retailer and Manufacturer Alliance (GRMA) is proud to introduce the Product Integrity Program, designed to advance public health and help ensure consumers have access to safe, high-quality products. Developed through consensus among several member companies— including retailers, brands, manufacturers, testing labs, trade organizations, and more — this program promotes transparency, credibility, and scientific integrity within the Dietary Supplement Category.

Consumers expect that the ingredients on the label are in the product:

  • Confirmed Identity & Composition
  • Specified Strength & Purity
  • Clear of Undeclared Adulterants
  • Free from Unacceptable Contaminants

Program Overview

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Participation in this program will identify top-tier labs for their expertise in verifying that dietary supplements meet Supplements Facts Panels (SFP) requirements.

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Recognition

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Qualified laboratories demonstrating conformance will be listed in the GRMA Lab Directory and have a unique GRMA logo that can be used for marketing purposes* which will highlight their specific capabilities.

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Participation Process

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Participating in the program is straightforward, involving eight steps from pre-application to annual monitoring.

Program participation is intended to be straightforward. Just follow these eight steps >>

Blockchain Technology - HealthLOQ

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Upon recognition by the GRMA program, labs must use GRMA-specified blockchain technology for customer-issued test reports or certificates of analysis and will receive a discount code for HealthLOQ.

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Application & Program Access

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Complete the application form to get started

or

Request more information about the program

FAQs

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Click for FAQs about the Product Integrity Program >>

Program Overview

The Product Integrity Program evaluates dietary supplement testing labs’ ability to establish fit-for-purpose methods that verify products against stated label claims for the “Big 5”: Identity, Composition, Strength, Purity, and Contamination. This assessment process includes both accredited and non-accredited labs and extends to those with internal calibration and stability programs.

Participation in this program will identify top-tier labs for their expertise in verifying that dietary supplements meet Supplements Facts Panels (SFP) requirements.

Program participation is restricted to independent labs with an applicable ISO/IEC 17025 accreditation from an iLAC signatory or qualified manufacturing labs with at least two years of conformance to the GRMA GMP program (details in the process below). 
This program assesses labs’ conformance to The Dietary Supplement Product Integrity Program requirements, which uses the following normative references:
  • 21 CFR 111
  • ISO 17025
  • ISO 17043
  • NSF/ANSI 173
  • GRMA, Inc Certification Program v1.2, NSF/ANSI 455-2 Dietary Supplements
  • AOAC Guidelines for Method Validation – Appendix K
  • ACIL Best Practices
  • FDA Foods Program Validation Guidance
Once a lab has successfully demonstrated conformance to the program requirements, they must issue test reports or COAs hashed with GRMA-specified blockchain technology to protect their brand, digital documents, and advance transparency.  
You can access the entire program by completing the following web form.

Recognition

Qualified laboratories demonstrating conformance will be listed in the GRMA Lab Directory, will be eligible to receive a program recognition, and will have a unique GRMA logo that can be used for marketing purposes* which will highlight their specific capabilities.

*specific GRMA logo terms and conditions apply.

GRMA members are constantly seeking qualified labs for product testing. Putting your lab on the recognized & qualified laboratories list within the GRMA Lab Directory will highlight your lab’s specific and demonstrated capabilities to the program’s requirements.

Additionally, labs that are part of the program will have the benefit of providing verified documents to retailers including CoAs and other documents that can be validated by the retailer or consumers themselves through HealthLOQ’s blockchain technology.

This will be a great marketing tool for laboratory clients and future clients. Since the dietary supplement category contains several product formats and types with fewer published methods, program recognition will highlight the following laboratory capabilities:

  • Product Types (like Vitamins & Minerals, Herbs/Botanicals, Amino Acid, Enzymes & Probiotics, Metabolites, Constituents, Extracts, Combinations, etc.)
  • Testing Capabilities (Identify, Composition, Strength, Purity, Contaminate, etc.)
  • Testing Technologies (Calibration, Microbiological, Chemistry, etc.)
  • Testing Equipment Types (MS, Chromatography, HPTLC, etc)

Participation Process

Participating in the program is straightforward, involving eight steps from pre-application to annual monitoring.

Program participation is intended to be straightforward.

Just follow these eight steps:

The Dietary Supplement Product Integrity Program provides access to program participation in two different types of labs:

  • Independent Lab: Must have an active ISO/IEC 17025 accreditation (ILAC signatory) covering their scope of work within Dietary Supplements.
  • Manufacturing Lab: Must have two years of GRMA GMP audits with the applying lab identified within the scope of the GMP audit reports & certificate, a grade of B (or higher), and less than two major and 11 minor non-conformances (combined across both audits).

Qualified labs can complete the application form after meeting the pre-application requirements and reviewing the program requirements. The application helps us scope the assessment and requires details on:

  • Testing Technologies (Calibration, Micro, Chemistry, etc.)
  • Testing Equipment (HPLC, HPTLC, GS-MS, etc.)
  • Product Types (Vitamins & Minerals, herbs/botanicals, Amino Acid, Enzymes & Probiotics, Metabolites, Constituents, Extracts, Combinations)
  • Testing Capabilities (Identification, Composition, Purity, Strength, Contaminant, Stability, etc.)

We will contact you once the application is complete to provide an estimate assessment cost, assessment agreements, and proposed scheduling.

Apply by completing the following form – https://grmauditorder.wufoo.com/forms/rhborlv0vfks0p/

or

Request more information about the program

  • Once the application and agreements are in place we will provide you with a pre-assessment checklist.  This checklist is also available to members on the member portal.
  • Prepare for the pre-assessment meeting and submit pre-assessment documents, including:
    • GRMA Certificate & Report or ISO 17025 Accreditation
    • Overview of Regulatory Activity (past five years)
    • Master List of Methods
    • Reference Sample Requirements
    • Evidence of Calibrations
    • Overview of Proficiency Testing Program
    • Test Method Validation/Fit for Purpose Procedure
    • Lab Organization Chart

Host the assessor onsite to demonstrate compliance with the GRMA program requirements. This includes demonstrating testing procedures and adherence to the GRMA checklist. The assessor will conduct opening and closing meetings, provide daily recaps, and present a final summary, covering an overview of the assessment, positive feedback, observations, and any findings. Additionally, the lab must demonstrate the utilization of GRMA specified blockchain technology, HealthLOQ.

During this stage, multiple steps must occur:

  • Assessor will finalize the assessment report
  • The assessment report is submitted for a qualified technical review
  • The final report is provided to the laboratory including any findings identified
  • If findings are identified during the assessment process:
    • The laboratory performs corrective actions on all findings
    • The laboratory submits evidence of corrective actions and implementation
    • Assessor reviews responses to all findings for suitability and evidence of implementation
    • GRMA approves if acceptable.
    • If responses to findings are not acceptable on first review, the GRMA will require additional clarification/information/action(s)

The accreditation body will determine if an accreditation scope extension is warranted, and the GRMA will decide if a Letter of Attestation is warranted.

Once the GRMA Letter of Attestation or Accreditation Scope Extension is awarded, all future lab reports issued using the specified blockchain technology will identify the lab’s participation within the GRMA program. These hashed documents then have the ability to be verified for both authenticity by your customer (i.e. brand, manufacturer, retailer, etc.) and provide verification of the labs qualification within the GRMA program. Additionally, the lab will be identified as qualified in the GRMA directory.

The lab must demonstrate conformance to the program requirements annually, including maintaining ISO 17025 accreditation or GRMA GMP certification.

Blockchain Technology – HealthLOQ

Upon recognition by the GRMA program, labs must use GRMA-specified blockchain technology for customer-issued test reports or certificates of analysis and will receive a discount code for HealthLOQ.

Upon successfully completing and being recognized by the GRMA program, labs will be required to use a GRMA-specified blockchain technology for any customer-issued test report or certificate of analysis. As a program perk, all recognized participants will receive a discount code to use HealthLOQ.

HealthLOQ leverages zero-knowledge proof, blockchain, and cryptography technologies to protect and validate digital documents without breaching confidentiality requirements. Original, authentic documents are processed through an irreversible one-way encryption within the document publisher’s own server environment, resulting in a unique “digital fingerprint” of the document. This digital fingerprint is then stored on an unalterable blockchain ledger and is perpetually available for comparison against the digital fingerprint of any purported authentic documents.

The HealthLOQ document integrity protocol:

  • Enables the automated verification that documents are authentic, original and unaltered.
  • Provides transparency to the verified digital authorization chain for the product/supplier qualification process.
  • Preserves the privacy of the document’s content, no exposure of proprietary/sensitive information.
  • Enables reliance on electronic documents per 21 CFR Part 11, saving money on redundant testing.
  • Protects consumers, manufacturers, retailers, and third-party labs against adulterated, unauthentic, and counterfeit products.
  • Is easy to implement and non-disruptive to existing workflows.
  • Potentially reduces the cost of liability insurance for manufacturers, retailers, and labs

FAQs

A: The GRMA Product Integrity Program is a lab conformance assessment and recognition program that is designed to advance public health and product quality by evaluating dietary supplement testing labs’ ability to verify products against stated label claims for Identity, Composition, Strength, Purity, and Contamination.

A: While ISO 17025 accreditation may be limited to some testing technologies and test methods, the GRMA Product Integrity Program will seek evidence of conformance for all of the in-scope capabilities. Additionally, the program specifies several normative references that will be used to assess the lab’s quality system, test methods, testing capability & execution, and more. This assessment process will also include random sampling and assessments of test methods that are not listed on the accreditation certificate against program requirements. This enables qualified accredited labs to provide a specific GRMA scope extension to their accreditation from participating accreditation bodies.

A: Participation is open to independent labs with an applicable ISO/IEC 17025 accreditation from an iLAC signatory and qualified manufacturing labs with at least two years of conformance to the GRMA GMP program.

A: While ISO 17025 accreditation may include a variety of testing technologies and methods covering a wide range of product types, the GRMA Product Integrity Program focuses exclusively on the testing of dietary supplements. The GRMA program utilizes specific technical requirements from industry-specific normative references documents and has been designed to specifically assess a dietary supplement testing lab’s quality system, test methods, testing capabilities, and execution. GRMA requires laboratories to provide evidence of conformance for all in-scope technical capabilities, including GRMA program requirements. The GRMA assessment process includes random sampling of applicable dietary supplement related 17025 accredited test methods and a full assessment of GRMA program specific test methods specifically listed in the GRMA certificate to ensure compliance with program requirements. This enables qualified 17025 accredited labs to extend their GRMA scope through participating accreditation bodies.

A: Benefits include recognition in the GRMA Lab Directory, GRMA-specified blockchain technology for test reports, and a discount code for HealthLOQ. These enhance marketing capabilities and protect against adulterated, unauthentic, and counterfeit products.

A: HealthLOQ uses zero-knowledge proof, blockchain, and cryptography to protect and validate digital documents without breaching confidentiality. It enables automated verification of document authenticity, preserves content privacy, supports compliance with 21 CFR Part 11, and potentially reduces liability insurance costs. Find out more at HealthLOQ.

A: The program is open to Independent Labs with an applicable ISO/IEC 17025 accreditation and qualified Manufacturing Labs with two years of GRMA GMP audits.

A: There are 3 primary components with the application process.

  • Complete the application form
  • Align on the assessment scope & complete the assessment agreement
  • Establish an agreed to date/time to host the assessment

Contact Us

Looking for more information about the program, the process, becoming a member, or something else? Please reach out. We’d love to hear from you! Fill out our contact form and we’ll be in touch with you soon.

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