How to use this document
Copy the template below into your quality system. Replace every <<FILL: ...>> placeholder with your company, system, and process specifics, then route it through your own document control, review, and approval. The filled specimen shows one worked example; adapt the numbers and scope to your operation and verify each cited regulation or standard against the current source before you rely on it.
This is a generic, originally worded starting point. It contains no confidential, proprietary, or employer material, it is drafted with AI assistance and reviewed, it is not legal or compliance advice, and adopting it does not by itself create or prove compliance. See the Disclaimer and Terms.
This is a ready-to-use comparison for checking a live quality agreement against the elements FDA’s 2016 quality agreement guidance recommends and the EU GMP Chapter 7 no-silent-subcontracting expectation. Replace every <<FILL: ...>> placeholder. Run this on a defined cadence and whenever the network changes shape, not only at signature. A filled specimen follows.
Element-by-element comparison
Reference and retention sample custody is worth checking on its own line rather than assuming it is implicit in “manufacturing activities allocated by party.” The European Commission published an updated Annex 19 (Reference and Retention Samples) to EudraLex Volume 4 on 24 June 2026, and PIC/S folded the same revision into its own GMP Guide effective 24 September 2026. Two changes matter for a CDMO relationship specifically: a sample may now be kept as a photograph or other digital record instead of a physical unit, if the arrangement meets conditions the annex sets out, and the annex now speaks more directly to who holds a sample when a product passes through more than one distributor before reaching the patient. Where a CDMO holds retention samples on the sponsor’s behalf, the agreement should name which party holds them, in what format, and for how long, and that naming should be checked against the current annex rather than carried forward from a quality agreement drafted before the 2026 update existed.
Findings and disposition
Score each finding as a document gap, the agreement’s text needs an amendment, or an operational gap, the text is adequate but the practice does not match it. An operational gap is the more serious class: amending the agreement’s language does not close it.
Approvals
Filled specimen
Acme Therapeutics ran this assessment on its quality agreement with CMO Alpha two years after signature, triggered by CMO Alpha’s onboarding of a fourth-party analytical lab.
Findings and disposition
Findings 1 and 4 close by amending the agreement’s text. Finding 3 does not close by amendment alone; it requires confirming the fourth-party lab itself meets the qualification standard the agreement would have required had it been submitted for approval, the more serious operational-gap class this assessment exists to surface.
Common inspection findings this assessment prevents
- A quality agreement that reads complete at signature and has never been checked against its own recommended elements since, so a gap is discovered only when an event falls into it.
- A notification timeline defined for critical deviations with no equivalent for major ones, leaving a real gap in practice that neither party notices until it costs a delayed notification.
- Subcontracting that occurred without the sponsor’s prior written approval because no one checked the agreement’s own clause against what the network actually did.
