Quality Agreement Pharma Template and Key Clauses (2026)

What is a pharma quality agreement, and when do you need one? A pharmaceutical quality agreement, sometimes called a quality technical agreement or QTA, is a written contract between a product owner and a contract facility that defines which party is responsible for each GMP (Good Manufacturing Practice) activity when manufacturing, testing, packaging or storage is outsourced. It sits alongside the commercial supply agreement but covers only quality: specifications, testing, release, deviations, changes, complaints, recalls and audits. You need one whenever a marketing authorisation holder or brand owner uses a contract manufacturer (CMO or CDMO), a contract testing lab, a packer or a contract storage provider. The point is simple: the owner stays responsible for the product, but the day-to-day work is done by someone else, so you must write down who does what. Without it, deviations and out-of-specification results turn into arguments about whose job it was. The US FDA set out its expectations in the 2016 guidance "Contract Manufacturing Arrangements for Drugs: Quality Agreements". In the EU, the requirement lives in EU GMP Chapter 7, "Outsourced Activities". Both make the same core point: outsourcing a task never outsources the responsibility. (Last verified October 2026.) This article is general guidance, not legal or regulatory advice. GMP obligations vary by jurisdiction and product type, so have a qualified quality and regulatory professional review any agreement before you rely on it. ## Pharma quality agreement template Copy the block below and fill the bracketed fields. Treat the responsibility table as the heart of the document. ```

QUALITY AGREEMENT This Quality Agreement ("Agreement") is made on [DATE] BETWEEN: [OWNER NAME], [address] (the "Owner") AND [CONTRACT FACILITY NAME], [address] (the "Contract Facility") 1. PURPOSE AND SCOPE This Agreement defines the GMP responsibilities of each party for [product(s) / activity: manufacture / testing / packaging / storage]. It governs quality only. Commercial terms are in the Supply Agreement dated [DATE]; if the two conflict on a quality matter, this Agreement prevails. 2. DEFINITIONS AND APPLICABLE STANDARDS The parties will comply with applicable GMP, the marketing authorisation(s), the agreed specifications, and [FDA 21 CFR 210/211 / EU GMP / ICH Q7 / local GMP code], as relevant to each market. 3. RESPONSIBILITY MATRIX For each activity, R = responsible, A = approves, C = consulted: Activity Owner Contract Facility Raw material specifications A R Supplier qualification C R Manufacture to the process - R In-process and release testing C R Batch record review A R Final disposition / release R C Deviation handling A R Change control A R Stability program [ ] [ ] Complaint investigation R C Recall decision R C 4. SPECIFICATIONS AND TESTING The approved specifications and test methods are in Appendix [X]. Changes require written approval under clause 8. 5. BATCH RELEASE AND DISPOSITION The Contract Facility manufactures and performs testing; the Owner's quality unit (or Qualified Person, where required) makes the final disposition decision and is responsible for release of product to the market. 6. DEVIATIONS AND OUT-OF-SPECIFICATION (OOS) RESULTS The Contract Facility will record, investigate and document all deviations and OOS results, notify the Owner within [N] business days for events affecting product quality, and not release affected batches without Owner approval. 7. DOCUMENTATION AND DATA INTEGRITY Records follow ALCOA+ principles (attributable, legible, contemporaneous, original, accurate, and complete, consistent, enduring, available). Retention period: [N] years or as law requires. 8. CHANGE CONTROL No change to materials, process, equipment, site, method or subcontractor that could affect product quality or the marketing authorisation may be made without the Owner's prior written approval. 9. SUBCONTRACTING The Contract Facility may not subcontract any GMP activity without the Owner's prior written consent; the Owner retains the right to audit any approved subcontractor. 10. AUDITS AND INSPECTIONS The Owner may audit the Contract Facility [frequency] and for cause. The Contract Facility will notify the Owner of any regulatory inspection affecting the product within [N] business days and share relevant findings. 11. COMPLAINTS, RECALLS AND RETURNS The parties will cooperate on complaint investigation; the Owner leads any recall decision; roles and timelines are in Appendix [X]. 12. TERM, TERMINATION AND ANNEX REVIEW This Agreement runs from [START] and is reviewed at least every [N] years. On termination, open batches, records and samples are handled per clause [X]. 13. GOVERNING LAW This Agreement is governed by the laws of [jurisdiction]. Signed for the Owner: __________ Signed for the Contract Facility: ______ Quality unit / date Quality unit / date

- **Responsibility matrix (clause 3).** This is the clause auditors read first. Go activity by activity and mark exactly one responsible party for each. Leaving a row blank or marking both parties is the most common finding. Add rows for your product: sterility assurance, environmental monitoring, reserve samples, label control.
- **Batch release (clause 5).** Spell out that the contract facility manufactures and tests, but the owner's quality unit makes the final disposition decision. In the EU this is tied to the Qualified Person; in the US the owner's quality unit stays legally responsible for approving or rejecting product, including final release.
- **Deviations and change control (clauses 6 and 8).** Set notification timelines in business days and require owner approval before any change that could touch the marketing authorisation. Undocumented changes at the contract site are a frequent cause of warning letters.
- **Subcontracting and audits (clauses 9 and 10).** Require written consent for subcontracting and keep audit and inspection-notification rights. EU GMP Chapter 7 expressly requires the right of audit to flow down to subcontractors. ## Common mistakes to avoid - A responsibility matrix with gaps or shared rows, so no one clearly owns an activity.
- Mixing quality and commercial terms in one document, which makes the quality agreement hard to audit and update.
- No deviation or OOS notification timeline, so the owner learns of problems too late.
- Silent subcontracting, where the contract facility passes work to a third party the owner never approved or audited.
- Treating the agreement as a one-time document instead of reviewing it on a fixed cycle as processes and sites change. ## A note on jurisdiction The GMP framework varies by jurisdiction, even though the principles rhyme. In the United States, the FDA's 2016 quality agreement guidance is non-binding but reflects its expectations under 21 CFR Parts 210 and 211, and the owner's quality unit keeps legal responsibility for release. In the European Union and EEA, EU GMP Chapter 7 requires a written contract that defines responsibilities and communication, and release is linked to a Qualified Person. In India, GMP is governed by Schedule M of the Drugs and Cosmetics Rules (revised and phased in from 2024) under CDSCO oversight, and loan-licence and contract-manufacture arrangements have their own conditions. Many quality agreements are global, so the safe approach is to list every applicable standard and market and say "varies by jurisdiction" rather than assume one GMP code covers all. (Last verified October 2026.) ## Where a contract workspace helps A template gives you a solid quality agreement. The ongoing work is keeping the responsibility matrix consistent across many contract facilities, reviewing each agreement for weak or missing clauses, tracking review dates and audit commitments, and governing versions as sites and processes change. One AI workspace tuned to how your company contracts can hold all of it. [Adira](https://adiralaw.com) is built for working this way, in a single place. This template alone is enough to put a fair quality agreement in place; the workspace keeps drafting, review and tracking connected.