Supplier quality agreements: what one covers and when a small lab needs one

What a quality agreement is

FDA's guidance Contract Manufacturing Arrangements for Drugs: Quality Agreements (November 2016) describes a quality agreement as a comprehensive written agreement that defines each party's manufacturing activities and how each will comply with good manufacturing practice, stating which party carries out each activity. [1] It should not cover business terms such as pricing, delivery or liability; FDA recommends keeping it separate from, or severable from, the supply contract. [1]

ICH Q7 sets the same expectation for contract manufacturers and laboratories: a written, approved agreement defining each party's quality responsibilities, a right for the contract giver to audit, no subcontracting without the giver's approval, and no changes to process, equipment, test methods or specifications unless the giver is informed and approves. [2]

Does it apply to research purchasing?

Not directly. FDA's guidance defines commercial manufacturing as excluding research and development and investigational material, and says the guidance does not explicitly apply to those stages. It adds that FDA believes quality agreements can be extremely valuable in research and development arrangements and that many of its principles could apply before commercial stages. [1]

A research lab buying catalogue peptides is not a drug owner contracting a manufacturer. It is a customer that wants predictable material and notice when something changes. That is a smaller need, and it can be met with a smaller document.

The typical sections, and what a research lab keeps

FDA lists the sections most agreements contain: purpose and scope, definitions, resolution of disagreements, manufacturing activities and change control, and the agreement's life cycle and revisions. Under manufacturing activities it covers quality unit responsibilities including audits, facilities and equipment, materials management, product-specific expectations such as specifications and lot numbering, laboratory controls, and documentation. [1]

A one-page letter of understanding

For a research supplier, a short letter signed by both sides captures the clauses that protect your data. Keep business terms out, as FDA recommends. [1]

• Scope: the products, catalogue numbers and grades covered.
• Specification: the supplier names the specification each lot is released against and sends it on request.
• Certificates: every shipment comes with a certificate of analysis for that lot, dated, with results and the name of the testing laboratory.
• Change notification: the supplier gives written notice, ideally a stated number of days ahead, before changing the manufacturing site, synthesis route, test method, specification or lot-numbering scheme. [1] [2]
• Nonconformance: the supplier informs you if a lot you received is later found out of specification.
• Subcontracting: the supplier says whether synthesis or testing is subcontracted and to whom. [2]
• Records: the supplier keeps lot records for a stated period and provides the certificate and, where possible, raw data on request.
• Contacts: named quality and sales contacts, with a response time.

When a supplier declines

Standard terms often point the other way. On 30 October 2026, OMNI Peptides' terms said product specifications, availability, pricing and packaging may change without notice and that products are provided as is. [3] Evolve Peptides' terms reserved the right to discontinue any product at any time and also disclaimed warranties beyond what is expressly stated. [4] Peptides EU's FAQ invited institutions to contact it about purchase orders and bulk orders but did not mention quality agreements. [5] We did not ask any of them to sign one.

If a supplier declines, record the request and the reply in your supplier file and compensate on your side: treat every new lot as a potential change, compare each certificate with the last, and run identity checks on receipt. The site's lot-change checklist sets out those steps. If your work depends on continuity, the refusal itself is a reason to qualify a second supplier.

When a small lab should push for one

Ask for at least the one-page letter when a study runs long enough to span several lots, when results will be compared across lots or sites, when you are moving towards regulated work, or when a sponsor or institution asks for supplier controls. For one-off exploratory purchases, a lot-specific certificate and a receiving record are usually enough.