This is a ready-to-use technical agreement, the operational counterpart to the quality agreement, that turns a CDMO technical assessment’s findings into binding, documented responsibility. It does not replace the quality agreement’s GMP-accountability provisions; it spells out, function by function, who does what across the manufacturing and testing relationship. Replace every <<FILL: ...>> placeholder and route the completed agreement through both parties’ document control and legal review before signature. A filled specimen follows.
Document control header
| Field | Entry |
|---|---|
| Document title | Technical Agreement between <<FILL: Sponsor name>> and <<FILL: CDMO name>> |
| Document number | <<FILL: e.g. TA-2026-07>> |
| Version | <<FILL>> |
| Effective date | <<FILL>> |
| Linked quality agreement | <<FILL: QA document number>> |
| Linked technical assessment / disposition register | <<FILL: ref>> |
| Product(s) / process(es) in scope | <<FILL>> |
1. Purpose
This agreement documents the technical responsibilities each party holds for the manufacture and testing of <<FILL: product>> at <<FILL: CDMO site>>, translating the findings and dispositions of the technical assessment referenced above into terms both parties can act on and be held to.
2. Scope
This agreement covers the technical and operational conduct of manufacturing and testing; it does not restate the quality agreement’s GMP-accountability, disposition-authority, or regulatory-reporting provisions, which remain governed by that document. Where this agreement and the quality agreement conflict, the quality agreement governs GMP accountability and this agreement governs operational and technical detail.
3. Policy statements: responsibility by function
| Function | Sponsor responsibility | CDMO responsibility |
|---|---|---|
| Raw material and component release | <<FILL: e.g. approves the CDMO's supplier qualification for sponsor-critical materials>> | <<FILL: e.g. performs incoming release testing and dispositions per the approved specification>> |
| In-process control | <<FILL: e.g. reviews IPC trend data on the agreed schedule>> | <<FILL: e.g. executes and documents IPC testing per the master batch record>> |
| Environmental monitoring | <<FILL: e.g. receives EM excursion notifications within the agreed timeframe>> | <<FILL: e.g. owns EM program design, execution, and trending>> |
| Change control | <<FILL: e.g. reviews and approves changes affecting a critical quality attribute before implementation>> | <<FILL: e.g. initiates change control, provides comparability data, notifies sponsor per section 4>> |
| Deviation investigation | <<FILL: e.g. reviews deviation and CAPA data before disposition of affected batches>> | <<FILL: e.g. owns investigation, root cause, and CAPA per its own procedures>> |
| Analytical methods | <<FILL: e.g. owns method validation for sponsor-developed methods>> | <<FILL: e.g. executes transferred methods, maintains instrument qualification per USP <1058>> |
| Data ownership and access | <<FILL: e.g. retains right to raw data and audit trail access for regulatory purposes>> | <<FILL: e.g. provides data access within the agreed timeframe and format>> |
| Person-in-plant access | <<FILL: e.g. names the individuals authorized as PIP for this program>> | <<FILL: e.g. grants access per the PIP Campaign Readiness Checklist for each campaign>> |
4. Notification and communication commitments
| Event | Notification window | Recipient |
|---|---|---|
| Change control affecting a critical quality attribute or critical process parameter | <<FILL: e.g. 30 days before implementation>> | <<FILL: sponsor technical contact>> |
| Deviation classified as major or critical | <<FILL: e.g. within 24 hours of classification>> | <<FILL>> |
| Planned facility or equipment change affecting the qualified state used for this program | <<FILL>> | <<FILL>> |
| Regulatory inspection observation relevant to this program | <<FILL: e.g. within 5 business days>> | <<FILL>> |
5. Roles
| Role | Responsibility |
|---|---|
| Sponsor technical contact | Primary recipient of CDMO notifications under section 4; owns the sponsor side of change-control review |
| CDMO technical contact | Primary point of contact for sponsor technical queries; owns notification timeliness under section 4 |
| Sponsor quality unit | Retains ultimate product-quality responsibility per the quality agreement; resolves any conflict between this agreement and the quality agreement |
| CDMO quality unit | Retains GMP and disposition accountability per the quality agreement |
6. Compliance and exceptions
Any deviation from the responsibilities in section 3, or the notification windows in section 4, is itself logged as a finding in the CDMO Finding Disposition Register and dispositioned, not silently absorbed into practice. A recurring exception to a stated notification window is a trigger for renegotiating this agreement’s terms, not a reason to keep granting informal extensions.
7. References
FDA guidance, “Contract Manufacturing Arrangements for Drugs: Quality Agreements” (November 2016). EU GMP Chapter 7, Outsourced Activities. ICH Q10, Pharmaceutical Quality System, Section 2.7.
Confirm the current version of each reference before issue.
8. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
9. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Sponsor Technical Operations | <<FILL>> | ||
| Sponsor Quality Assurance | <<FILL>> | ||
| CDMO Technical Operations | <<FILL>> | ||
| CDMO Quality Assurance | <<FILL>> |
Filled specimen
Extract from the technical agreement between Acme Therapeutics and Meridian Fill Services for ATX-410 lyophilized biologic fill-finish.
| Function | Sponsor responsibility | CDMO responsibility |
|---|---|---|
| Change control | Reviews and approves any change to lyophilization cycle parameters, stopper specification, or container closure before implementation | Initiates change control at least 30 days ahead for changes affecting a CQA, provides bridging or comparability data per the change type |
| Person-in-plant access | Names J. Alvarez and two backup individuals as authorized PIPs for this program | Grants badge access and video feed credentials within 5 business days of a PIP assignment notice |
Notification example in practice: Meridian notified Acme’s technical contact on 2026-07-28 of a planned stopper supplier change, 34 days ahead of the planned implementation date, triggering the comparability sampling plan under change control CC-2026-014 and a PIP assignment for the first post-change batch.
Common findings this agreement prevents
- No document exists translating technical assessment findings into binding responsibility; the assessment record and the operating relationship diverge within the first year.
- Change-control notification happens informally by email with no committed timeframe, discovered only when a change is implemented with less notice than the sponsor needed to react.
- PIP access rights assumed rather than documented, creating the exact standoff a documented technical agreement exists to prevent.
- A responsibility, such as instrument qualification under USP <1058>, assumed by both parties to be the other’s job, discovered only during an audit or an inspection.
How to adapt this agreement
- Populate section 3 directly from your technical assessment’s disposition register, not from a generic template of responsibilities.
- Set real notification windows in section 4 that both parties have actually agreed to, not aspirational numbers neither side can meet.
- Route through both parties’ legal review in addition to quality and technical sign-off before signature.
- Review and reissue this agreement whenever the underlying quality agreement changes, so the two documents never drift apart.