What a Quality Agreement With a Peptide Manufacturer Should Cover
A quality agreement is a written document between a brand owner and its contract manufacturer that says which party performs and approves each quality-related activity: specifications and changes to them, testing and release, lot records, deviations, complaints, labeling, records, audits and subcontracting. It divides the work but does not move responsibility: FDA texts written for drugs say the owner stays responsible for its own labeling and for overseeing its contractor, whatever the paper says.
This guide is a checklist for owners and procurement staff at research-use-only (RUO) peptide brands that outsource manufacturing under private label or white label arrangements. It uses FDA’s guidance “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (November 2016) as a reference model for the structure of an agreement. That guidance is written for drugs. Using it as a model is not a claim that research peptides are drugs, and not a claim that any supplier follows it. This is not legal advice; an attorney should draft the final agreement.
What does a quality agreement cover?
| Topic | What the agreement settles |
|---|---|
| Scope and roles | Products and services covered, who performs and who approves each activity, named contacts |
| Specifications and change control | The agreed specification per product, and how changes are proposed, reviewed and approved |
| Testing and release | Which tests run, who runs them, who sees the data, who releases a lot |
| Lot records and traceability | What each lot record holds, how lots are numbered and traced |
| Deviations and out-of-specification results | How a departure or failing test is reported, investigated and closed |
| Complaints and withdrawals | How complaints are logged and shared, who decides on a withdrawal |
| Labeling | Who designs, approves, prints and applies the label, and who controls label masters |
| Records, audits, subcontracting | Retention periods, audit rights, approval of any work passed to a third party |
How is it different from a supply contract?
The 2016 FDA guidance says a quality agreement should not cover general business terms such as confidentiality, pricing or cost issues, delivery terms or limits on liability, and recommends that it be a separate document, or at least severable, from commercial contracts such as supply agreements. For a brand owner the practical point is that quality duties should survive a renegotiation of price or volume. The guidance lists the sections most agreements contain: purpose and scope, definitions, resolution of disagreements, manufacturing activities, and a clause on revising the agreement itself.
Who does what, and who signs off?
The guidance recommends that an agreement state clearly which party, the owner, the contract facility or both, carries out each activity, in a chart, matrix or narrative, and who has final approval for various activities. For a brand, the questions that matter most are release and communication: who approves a lot for shipment, what that person must see first, and who the named contacts are on each side. Assigning an activity to one party does not relieve the other of its own obligations.
How are specifications and changes controlled?
The guidance says some changes should be reviewed and approved by the owner before they are made, while others a contractor may make without notice, and the agreement should spell out which are which. Its list of change topics is a useful starting point: components and their suppliers, site locations, manufacturing processes, testing procedures, major equipment, shipping methods, lot numbering scheme, container closure systems, tamper evidence features and distribution. A brand owner can add label artwork, the vial and stopper specification, and the identity of any outside testing laboratory. The test is simple: if a change could alter what is in the vial, what the document says about it, or how a lot is traced, require advance written approval.
How should testing, release and lot records work?
Specify who tests what and who sees the data. A brand owner can require that every lot be tested by an independent third-party laboratory and that the laboratory’s report reach the brand owner unchanged, so the certificate of analysis (COA) attached to a lot is the laboratory’s own document and not a retyped summary. The guidance recommends procedures for passing all laboratory test results from the contract facility to the owner for use in final disposition decisions.
Lot records belong in the same section. Agree what each lot record contains, how lots are numbered, and how a finished lot links back to the materials and steps behind it. The guidance asks the agreement to cover lot numbering, lot disposition, and how traceability is kept when a facility works for more than one owner. It also asks that electronic records be retrievable during the required record-keeping time frames, so state the retention period and who holds the originals.
What happens with deviations, complaints and withdrawals?
At a principle level, the agreement should answer in writing: how fast must the manufacturer report a deviation or a failing test? Who investigates, and who sees the written conclusion? Who decides whether a lot is released, held or rejected afterwards? How are complaints received, shared and answered? The guidance says an agreement should explain how deviations are reported to the owner and investigated, recommends that the agreement designate who investigates out-of-specification results in the laboratory, and lists complaints and product recalls among the unexpected events that may require changes to processes and procedures. For a recall or market withdrawal, say who may start one, who notifies customers, and how quickly each party informs the other.
Who is responsible for the label, audits and subcontractors?
Decide who writes label text, who approves it, who prints and applies it, and how a change is made. Responsibility for the content stays with the brand. Under 21 CFR 201.128, intended use is “the objective intent of the persons legally responsible for the labeling of an article”, and it can be shown by “labeling claims, advertising matter, or oral or written statements by such persons or their representatives”. The same section says that if “a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.”
For audits, the guidance recommends that the agreement allow the owner to audit the contract facility, routine and for-cause, and say how findings are communicated. For subcontracting, it reports that ICH Q7 recommends written agreements that “define considerations for subcontracting”. In practice, require the manufacturer to name each step it passes to a third party, obtain the brand’s approval first, and pass the same duties down.
Can an agreement transfer regulatory responsibility?
No. The guidance, which concerns drug manufacturing quality rules, says a quality agreement cannot be used to delegate a party’s responsibility to comply with those rules, and that each party engaged in making a drug is responsible for complying with those rules for the manufacturing activities it performs. In 21 CFR 200.10(b), FDA “regards extramural facilities as an extension of the manufacturer’s own facility”, including “contract packers or labelers”.
FDA has said the same in warning letters to drug firms. Letter MARCS-CMS 721916 (letter 320-26-61; April 9, 2026, CDER), to a contract facility: “You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners.” Letter MARCS-CMS 715880 (letter 320-26-30; December 18, 2025, CDER), to a firm that uses contract facilities: “You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities.”
These texts concern drugs. This guide found no FDA statement on a contract manufacturer’s responsibility for the intended use created by its customers’ marketing, and does not imply one. The reading for a brand owner is narrower: divide the work clearly in writing, then keep your own oversight, records and labeling decisions.
Private Label Peptides offers private label and white label labels designed, printed and applied in-house. Every lot is tested by an independent third-party laboratory and has its own COA, and PLP attaches the laboratory’s report unchanged.
Last reviewed: 2026-11-13
References
- Contract Manufacturing Arrangements for Drugs: Quality Agreements, Guidance for Industry. U.S. Food and Drug Administration. November 2016. https://www.fda.gov/media/86193/download
- 21 CFR 200.10, Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers. eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-200/section-200.10
- 21 CFR 201.128, Meaning of “intended uses”. eCFR, 86 FR 41401, August 2, 2021. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-201/subpart-D/section-201.128
- FDA warning letter MARCS-CMS 715880 (letter 320-26-30), December 18, 2025, Center for Drug Evaluation and Research. FDA warning letters database, fda.gov.
- FDA warning letter MARCS-CMS 721916 (letter 320-26-61), April 9, 2026, Center for Drug Evaluation and Research. FDA warning letters database, fda.gov.
Frequently asked questions
Is a quality agreement the same as a supply contract?
No. FDA's 2016 guidance on quality agreements says they should not cover general business terms such as confidentiality, pricing, delivery terms or limits on liability, and recommends keeping them separate from, or at least severable from, the supply agreement.
Does a quality agreement make the manufacturer responsible for the brand's label?
Not for the brand's own statements. Under 21 CFR 201.128, intended use is the objective intent of the persons legally responsible for the labeling. An agreement can say who prints and applies a label, but the brand owner's labeling and statements remain its own.
Can responsibility be handed to the manufacturer in writing?
FDA's texts say not. The 2016 guidance, written for drug manufacturing quality rules, says quality agreements cannot be used to delegate responsibility for complying with those rules, and two FDA warning letters to drug firms say the firm is responsible regardless of agreements with its contract partners.
Do these FDA texts apply to research peptides?
They are written for drugs. This guide uses the 2016 guidance as a reference model for how to structure an agreement, not as a statement that research peptides are drugs or that any supplier meets drug rules.