A pharmaceutical quality agreement template is the starting point for the document that defines, in writing, who does what when a GMP activity is outsourced: contract manufacturing, packaging, laboratory testing, sterilisation, distribution or GxP IT services. It is not a commercial formality but an explicit regulatory requirement: Chapter 7 of the EU GMP Guide requires every outsourced activity to be "appropriately defined, agreed and controlled" through a written contract, and the FDA has dedicated a specific guidance to the topic. In audits and inspections, a missing, generic or outdated quality agreement is among the most frequent findings in supplier management. In this guide we look at what the document must contain, how to split responsibilities between Contract Giver and Contract Acceptor, and which mistakes to avoid.
What a pharmaceutical quality agreement template covers and when you need one
A pharmaceutical quality agreement is the technical agreement on quality that accompanies (and remains separate from) the commercial contract between two companies: on one side the client (Contract Giver, often the marketing authorisation holder or the site certifying the batch), on the other the performer (Contract Acceptor: CMO/CDMO, contract laboratory, warehouse, service provider). The principle is simple: responsibility for product quality is never outsourced. You outsource the activity, not the accountability.
A quality agreement is needed whenever a GMP-covered activity leaves the perimeter of your own site, typically for:
- contract manufacturing and packaging (in full or in part, including secondary packaging);
- quality control testing entrusted to external laboratories;
- sterilisation, storage and transport activities;
- services impacting GxP data, such as hosting and maintenance of computerised systems.
The regulatory framework: EU GMP Chapter 7, FDA and ICH Q10
On the European side the reference is Chapter 7 of EudraLex Volume 4 ("Outsourced Activities"), in force in its current revision since 31 January 2013. The chapter structures the subject in three blocks: duties of the Contract Giver (assessing the legality, suitability and competence of the acceptor before outsourcing; providing all necessary information; monitoring performance; reviewing records), duties of the Contract Acceptor (having adequate premises, equipment, knowledge and personnel; not subcontracting without prior approval; not introducing unauthorised changes that impact quality) and the requirements of the written contract, which must state unambiguously who performs each step, guarantee the giver access to records and the right to audit.
On the US side, the FDA guidance "Contract Manufacturing Arrangements for Drugs: Quality Agreements" (final, November 2016) describes how owners and contract facilities should define and document their respective manufacturing activities to ensure CGMP compliance. Two key messages: the quality agreement is a technical document separate from commercial terms, and it cannot be used to transfer to the other party responsibilities that the law assigns to each — both parties remain subject to CGMP requirements for the activities they perform.
Upstream, ICH Q10 places the management of outsourced activities among the responsibilities of the Pharmaceutical Quality System: the giver's quality system must extend to the control and review of activities entrusted to third parties, with responsibilities defined in written agreements and continuous monitoring of supplier performance.
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What a quality agreement must contain: the essential sections
There is no mandatory format, but consolidated practice (aligned with the FDA guidance and EU Chapter 7) calls for a section-based structure with a responsibility matrix. The table below summarises the minimum content an auditor expects to find.
| Section | Expected content | Reference |
|---|---|---|
| Purpose and scope | Products, sites and activities covered; what is excluded | EU GMP 7.15 |
| Definitions and term | Shared terminology, effective date, periodic review | FDA guidance 2016 |
| Responsibility matrix | Who performs each step: production, QC, release, sample retention | EU GMP 7.15 |
| Change control and deviations | Which changes require the giver's prior approval; notification of deviations and OOS | EU GMP 7.12 |
| Subcontracting | No subcontracting without written approval | EU GMP 7.11 |
| Access to records and audits | Records available to the giver and right to audit, including sub-suppliers | EU GMP 7.16–7.17 |
| Documentation and data integrity | Who archives what, for how long, in which format | FDA guidance 2016 |
| Dispute resolution | Escalation mechanism for quality disagreements | FDA guidance 2016 |
Responsibilities: Contract Giver and Contract Acceptor
The most delicate part of the document is the responsibility matrix. Three practical rules help you write it defensibly:
- No "orphan" activities and no ambiguous double sign-off. Every step — from material sourcing to batch release — must have a single accountable party. "Both" boxes should be used sparingly and explained.
- Release stays with whoever certifies. The Contract Acceptor may test and manufacture, but batch certification and final quality decisions remain with the party holding legal responsibility: the quality agreement must say so explicitly.
- Initial qualification is not enough. Chapter 7 asks the giver to monitor and review the acceptor's performance over time: periodic audits, review of deviations and trends, quality KPIs. The quality agreement should define how and how often.
Typical findings in audits
- Quality agreement mixed with the commercial contract: prices and penalties alongside change control and OOS make the document unmanageable and slow to revise.
- Generic matrix: "the supplier operates according to GMP" does not say who approves an excipient change or who investigates an OOS.
- Expired or never-reviewed document: the agreement no longer reflects real processes (new products, new sites, added sub-suppliers).
- Undeclared subcontracting: the acceptor has outsourced a step (e.g. sterilisation) without the giver's written approval.
- No timely notification duty for critical deviations, OOS results or regulatory inspections received by the supplier.
GuideGxP recommendation
Treat the quality agreement as a living document of the quality system, not a legal annex: give it a QA owner, a version number and a review date (typically every three years, or at any relevant change). Before signing, cross-check it against the supplier's latest audit report: every gap found in audit should have a corresponding line in the responsibility matrix. And when you inherit an existing agreement, re-read it against the checklist in the table above: if a section is missing, that is a finding you are bringing in-house.
Negotiating and maintaining quality agreements is one of QA's key tasks: in GuideGxP's Operational Guide to the Pharmaceutical QA Manager Role you will find the complete framework to manage suppliers, contracts and the quality system in an audit-ready way.
