How to Write a Quality Agreement with Your Hemp Ingredient Supplier

A purchase order establishes what you're buying and at what price. A quality agreement establishes how the ingredient will be produced, tested, documented, and delivered — and what happens when something goes wrong. For B2B hemp ingredient buyers operating in the November 12 compliance environment, a quality agreement is not optional: it is the contractual foundation that makes your supplier's compliance documentation legally and commercially meaningful.

What a Quality Agreement Is

A quality agreement (sometimes called a quality technical agreement or supplier quality agreement) is a formal document executed between a buyer and a supplier that specifies the quality, testing, documentation, and compliance obligations of each party. It is separate from the commercial purchase agreement — it does not specify price or volume — but it is directly referenced by commercial agreements as the quality standard against which purchases are evaluated.

In pharmaceutical and food ingredient sourcing, quality agreements have been standard practice for decades. In hemp ingredient sourcing, they are relatively new — but the November 12 framework creates the same compliance accountability requirements that make quality agreements standard in other regulated ingredient categories.

Section 1: Scope and Parties

The quality agreement should clearly identify:

• The parties: Buyer legal entity and supplier legal entity, including addresses and relevant regulatory identifiers (USDA hemp producer license number, DEA laboratory registration number where applicable)
• The covered products: Specific hemp-derived ingredients covered by the agreement, identified by product name, SKU, and specification reference
• The term: Effective date and renewal or termination provisions
• The governing standard: Reference to the applicable compliance framework, including the November 12 federal hemp standard (0.4mg total THC per container, ISO 17025-accredited DEA-registered laboratory testing, synthetic cannabinoid prohibition, GMP manufacturing consistent with 21 CFR Part 111)

Section 2: Product Specifications

• Specification reference: Reference to the approved specification document for each covered ingredient, including the version date
• Specification change notification: Supplier must provide advance written notice (typically 30–60 days) of any proposed change to the product specification, manufacturing process, testing method, or laboratory used
• Acceptance criteria: The specific test results and limits that define a conforming lot

Section 3: Testing and Documentation Obligations

This is the most substantive section of a hemp ingredient quality agreement:

Supplier testing obligations:

• The specific tests the supplier will conduct on each lot (cannabinoid potency, total THC, pesticides, heavy metals, residual solvents, microbials)
• The testing methodology (HPLC for cannabinoid potency; GC for residual solvents; ICP-MS for heavy metals; etc.)
• The laboratory to be used, with accreditation and DEA registration status specified
• The timing of testing relative to shipment (testing prior to shipment; COA to be provided before or with shipment)

COA requirements:

• Specific elements that must appear on each COA (lot number, test date, test results, laboratory name and accreditation number, DEA registration number, analyst signature or equivalent)
• Total THC reporting format (must separately report THCA and delta-9 THC; must include total THC calculation)

Retention sample obligations:

• Supplier must retain a reference sample from each lot for a specified period (typically 12–24 months)
• Retained samples must be available for re-testing on reasonable request from buyer

Section 4: GMP and Manufacturing Obligations

• GMP standard: Specify the GMP framework the supplier operates under (21 CFR Part 111 for dietary supplement-grade; FDA food CGMPs; equivalent EU GMP)
• Facility audits: Buyer right to conduct or commission audits of the supplier's manufacturing facility on reasonable notice
• Manufacturing change notification: Supplier must notify buyer of any significant manufacturing change (new equipment, facility changes, processing changes) that could affect product quality

Section 5: Regulatory Compliance

• USDA licensing: Supplier confirms and warrants that all hemp used in covered products was produced under a valid USDA hemp production license or approved state plan
• Synthetic cannabinoid prohibition: Supplier warrants that no synthetic or chemically converted cannabinoids are used in or present in any covered ingredient
• November 12 compliance: Supplier confirms that all lots shipped after November 12, 2026 will be accompanied by COAs from DEA-registered, ISO 17025-accredited laboratories
• Regulatory change notification: Supplier must notify buyer within a specified timeframe (typically 5–10 business days) of any regulatory action, enforcement notice, or material change in compliance status

Section 6: Non-Conformance and Dispute Resolution

• Non-conforming lot procedures: What happens when a received lot does not meet specification — hold, testing, rejection, return or disposal procedures
• Recall and withdrawal: Procedures for managing a product recall or market withdrawal affecting a covered ingredient
• Dispute resolution: The mechanism for resolving quality disputes between buyer and supplier

Getting Started Without a Legal Team

A quality agreement does not require extensive legal involvement to execute. Many B2B hemp ingredient buyers use a straightforward template covering the sections above, executed as a simple written agreement signed by authorized representatives of both parties. The important thing is that the agreement exists, is specific to the covered ingredients and the applicable compliance standard, and is reviewed when the supplier or regulatory framework changes.

Low Gravity Hemp welcomes quality agreements as a standard component of supplier relationships. Contact our team to begin the quality agreement process for your ingredient sourcing program.