This is a ready-to-use register for tracking a CDMO, CMO, or contract testing laboratory relationship from a routine issue through escalation to, where it comes to that, termination and transition-out. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers, and route the completed register through your normal document control and records retention. A worked filled specimen follows the template. Verify each cited regulation against the current published source before you rely on it. This template is an educational reference for you to adapt to your own quality system, products, and regulatory context; it is not legal, regulatory, or professional advice.
A quality agreement’s audit rights and survival clauses only matter if someone is tracking whether they were exercised. This register is the single place a pattern of issues, a for-cause audit, a notice to cure, and, if it comes to that, a termination and transition, live as one traceable history rather than as separate emails and meeting notes nobody can reconstruct later.
Register control
| Field | Entry |
|---|---|
| Register reference | <<FILL: e.g. LOG-SQ-014>> |
| Version | <<FILL>> |
| Owner | <<FILL: role, e.g. Supplier Quality Lead>> |
| Contract site covered | <<FILL: CDMO / contract site name>> |
| Quality agreement reference | <<FILL: number and effective date>> |
| Governing procedure | <<FILL: SOP-ID for supplier escalation and termination>> |
| Review frequency | <<FILL: e.g. monthly at the supplier quality review, or on any new entry>> |
| Escalation route for overdue items | <<FILL: role or forum, and the trigger>> |
| Retention | <<FILL: period, at least matching the quality agreement's record-retention obligation>> |
Part A. The escalation ladder (reference, define once)
Most relationships that end badly did not fail suddenly. They failed through a series of issues that were each individually tolerable and never systematically escalated. Define the ladder once here and apply it consistently to every entry in Part B.
| Stage | Trigger | Escalation target | Timeline |
|---|---|---|---|
| 1. Routine issue | A deviation, a missed notification window, a single audit finding, handled through normal quality-agreement mechanics | Site quality contacts, both sides | Per the agreement’s standard response windows |
| 2. Pattern recognized | Repeated issues of the same type, a for-cause audit trigger, a trend the metrics dashboard surfaces (see Report: CDMO Periodic Performance Review) | Supplier Quality / External Manufacturing lead | <<FILL: e.g. within 10 business days of the pattern being recognized>> |
| 3. Joint quality council escalation | Raised to the governance forum the quality agreement defines | Joint quality council, both quality units | <<FILL: e.g. next scheduled or an emergency session within 5 business days>> |
| 4. Formal notice to cure | Written notice citing the specific agreement clause breached, with a defined cure period | Both quality units, legal notified | <<FILL: e.g. cure period 30 to 60 days per the agreement>> |
| 5. Termination decision | For cause (breach, failed cure, a data integrity event, adverse regulatory action) or for convenience (a business decision unrelated to quality performance) | Owner executive quality sign-off, legal | <<FILL: per the agreement's termination clause>> |
| 6. Transition-out execution | Runs under the same GMP discipline as any other manufacturing activity, not as a wind-down exempt from it | Owner technical/CMC, regulatory affairs, both quality units | <<FILL: per the transition plan timeline, section D>> |
Part B. Escalation log (running register)
One row per event. The same underlying issue keeps its issue reference as it moves up the ladder, so its full path from a routine issue to whatever it becomes is traceable in one filter, not scattered across separate records.
| Issue ref | Date | Issue / trigger | Escalation stage | Description | Decision / action | Owner | Status | Resolution date |
|---|---|---|---|---|---|---|---|---|
<<FILL: ESC-001>> | <<FILL>> | <<FILL>> | <<FILL: 1 to 6, per Part A>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Open / Monitoring / Escalated / Closed>> | <<FILL>> |
<<FILL: ESC-001>> | <<FILL>> | <<FILL: same issue, next stage>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
<<FILL: ESC-002>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Rule for this table: never close an issue by rolling it up into a generic “resolved” note. State what changed, who decided it, and when. A row that says only “handled” is not a record, it is a placeholder for one.
Part C. Termination decision record
Complete this section only if an entry in Part B reaches stage 5. Leave blank, marked “not applicable,” for a register with no termination.
| Field | Entry |
|---|---|
| Linked issue ref(s) | <<FILL>> |
| Termination type | <<FILL: For cause / For convenience>> |
| Triggering event or decision | <<FILL>> |
| Cure period offered (if for cause) | <<FILL: dates>> |
| Cure outcome | <<FILL: cured / not cured, with evidence>> |
| Termination notice date | <<FILL>> |
| Notice period per agreement | <<FILL>> |
| Effective termination date | <<FILL>> |
| Decision approved by | <<FILL: name, role>> |
| Survival clauses confirmed in effect (audit rights, confidentiality, record access) | <<FILL: Yes / No, reference the clause>> |
Part D. Transition-out tracking
Complete and update this table on a defined cadence from the notice date through cutover. Every row needs a named owner and a target date; “in progress” with no date is not a status.
| Element | Status | Owner | Target date | Verified complete (date) |
|---|---|---|---|---|
| Successor site (or owner’s own facility) identified and qualification status | <<FILL: identified / qualification in progress / qualified>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Technology retransfer to successor site (run per Protocol: Technology Transfer to a CDMO, reversed) | <<FILL: not started / in progress / complete>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Bridging stock status (validated inventory built to cover the qualification gap) | <<FILL: quantity on hand vs. target, expiry>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Regulatory filing status (site-change variation / supplement) | <<FILL: not filed / submitted / approved>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Records and raw-data custody pull (batch records, deviation history, audit trails, retained samples) | <<FILL: not started / in progress / pulled and verified readable>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Open batches at cutover, disposition path assigned | <<FILL: count and disposition owner, or "none open">> | <<FILL>> | <<FILL>> | <<FILL>> |
| Open investigations at cutover, completion owner assigned | <<FILL: count and completion owner, or "none open">> | <<FILL>> | <<FILL>> | <<FILL>> |
Gate: commercial distribution from a successor site does not begin until the regulatory filing row above shows approved, not merely submitted, unless the assessment concluded no filing was required and both quality units concurred in writing.
Part E. Closure confirmation
Complete before this register can be marked closed for the relationship. All rows must be Yes before closure.
| Check | Confirmed (Yes/No, date) |
|---|---|
| Every escalation-log entry in Part B is at status Closed | <<FILL>> |
| Termination decision record (Part C) complete, or marked not applicable | <<FILL>> |
| Every transition-out row (Part D) verified complete | <<FILL>> |
| Records and raw-data custody pulled and confirmed readable while the outgoing CDMO was still contractually obligated to cooperate | <<FILL>> |
| Every batch and investigation open at cutover has a documented completion, regardless of which side of the termination date it fell on | <<FILL>> |
| Approved-vendor list updated to reflect the terminated status | <<FILL>> |
References
EU GMP Chapter 7, Outsourced Activities. FDA guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements. ICH Q7, Good Manufacturing Practice for Active Pharmaceutical Ingredients, section 16. ICH Q10, Pharmaceutical Quality System, ongoing supplier performance management.
Confirm the current version of each reference before issue, and confirm with legal counsel what contract-law and jurisdiction-specific obligations govern the termination mechanics beyond the GxP framework; this register supports the operational and quality tracking of a termination, not the legal determination of when or how one may occur.
Retention
Retain this register, and every record it references, per the retention period in the register control table, at least matching the quality agreement’s record-retention obligation. Do not purge a closed relationship’s history; a released or terminated relationship’s escalation trail is itself evidence of why the outcome was reached.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
A completed extract for an illustrative CDMO relationship that escalated to termination for cause. Company, site, records, and dates are invented for teaching purposes.
Register control: LOG-SQ-014, version 1.0, owner J. Amaro, Supplier Quality Lead. Contract site: Halvergate Sterile Manufacturing, Leeds, United Kingdom. Quality agreement QAG-2025-041. Reviewed monthly at the supplier quality review.
Part B, escalation log
| Issue ref | Date | Issue / trigger | Stage | Description | Decision / action | Owner | Status | Resolution date |
|---|---|---|---|---|---|---|---|---|
| ESC-014 | 31 Mar 2026 | Notification-timeliness pattern, two-quarter worsening metrics trend | 1. Routine issue | Deviation-notification windows missed on 2 of 6 events in Q1; flagged in the Q1 CDMO Periodic Performance Review, CPR-2026-009 | Increased oversight decision recorded in CPR-2026-009: person-in-plant assigned for next two campaigns, biweekly metrics submission | J. Amaro | Monitoring | n/a, entered monitoring |
| ESC-014 | 22 Jun 2026 | Same pattern continues into Q2 despite increased oversight | 2. Pattern recognized | Q2 review shows investigation closure timeliness still below target (81% vs. 95%) and one further late serious-event notification (4 days late); the corrective action from Q1 did not resolve the root cause | For-cause audit triggered outside the routine cycle | J. Amaro | Escalated | n/a, escalated to stage 3 |
| ESC-014 | 10 Jul 2026 | For-cause audit findings | 3. Joint quality council escalation | For-cause audit (08 to 09 Jul 2026) found the quality unit staffing gap from Q4 2025 was never fully closed; 2 majors, 1 critical (an unreported OOS on a released-pending lot discovered only through the audit’s own record trace) | Raised to the joint quality council; corrective action plan requested with named owners and dates within 15 business days | R. Okonkwo, Head of External Manufacturing | Escalated | n/a, escalated to stage 4 |
| ESC-014 | 28 Jul 2026 | Corrective action plan reviewed | 4. Formal notice to cure | Halvergate’s plan proposed retraining and a temporary contractor, with no structural fix to the staffing model and no commitment to the quality unit headcount the site’s own SOPs require | Formal notice to cure issued, citing quality agreement clause 9.2 (notification) and clause 4.1 (adequate resourcing of the quality unit); 45-day cure period | R. Okonkwo | Escalated | n/a, escalated to stage 5 |
| ESC-014 | 15 Sep 2026 | Cure period outcome | 5. Termination decision | Day-40 check found the quality unit still 2 FTE short of its own staffing model and a second unreported deviation found in a targeted record pull; cure not achieved | Termination for cause approved | R. Okonkwo, with legal | Closed | 15 Sep 2026 |
| ESC-014 | 15 Sep 2026 | Termination notice issued | 6. Transition-out execution | Transition-out plan, drafted as a contingency when stage 2 began on 22 Jun 2026, activated the same day as the termination notice | Transition-out tracking opened in Part D | R. Okonkwo | Open | Tracked below |
Part C, termination decision record
| Field | Entry |
|---|---|
| Linked issue ref | ESC-014 |
| Termination type | For cause |
| Triggering event | Failed cure of a repeated notification and staffing-adequacy breach, plus a second unreported deviation found during the cure-period record pull |
| Cure period | 28 Jul 2026 to 11 Sep 2026 (45 days) |
| Cure outcome | Not cured: staffing gap remained, and a second unreported deviation was found |
| Termination notice date | 15 Sep 2026 |
| Notice period | 180 days per quality agreement clause 14.3 |
| Effective termination date | 14 Mar 2027 |
| Decision approved by | R. Okonkwo, Head of External Manufacturing, with Legal sign-off, M. Feathers |
| Survival clauses confirmed | Yes, audit rights, confidentiality, and record access confirmed to survive termination per clause 14.6 |
Part D, transition-out tracking (as of 20 Oct 2026, mid-transition)
| Element | Status | Owner | Target date | Verified complete |
|---|---|---|---|---|
| Successor site identified and qualified | Identified: Bramwell Sterile Manufacturing, an existing qualified secondary supplier for a related product; qualification audit for this product scheduled | R. Okonkwo | 30 Nov 2026 | Not yet |
| Technology retransfer | In progress, gap assessment complete, knowledge transfer package delivered 05 Oct 2026 | T. Nwosu, CMC | 15 Jan 2027 | Not yet |
| Bridging stock | 9 months of validated inventory built ahead of the notice period; sufficient to cover the qualification timeline plus a 2-month margin | Supply Planning | Built by 15 Sep 2026 | Yes, 18 Sep 2026 |
| Regulatory filing | Site-change supplement drafted, submission planned once the successor site’s engineering batch data is available | Regulatory Affairs | Submit 31 Jan 2027 | Not yet |
| Records and raw-data custody pull | In progress; batch records and deviation history for the prior 24 months pulled and verified readable; audit trail export for the CDS in progress | J. Amaro | 30 Nov 2026 | Partial, batch records and deviation history done 12 Oct 2026 |
| Open batches at cutover | 3 batches in Halvergate’s queue at notice date; all 3 completed and dispositioned before the notice period midpoint, none open at present | J. Amaro | n/a | Yes, 30 Sep 2026 |
| Open investigations at cutover | 1 investigation open (the second unreported deviation found during the cure period); Halvergate retains completion obligation per the survival clause, with owner-side monitoring | J. Amaro | 15 Nov 2026 | Not yet |
The detail that makes this defensible is the date on the transition-out plan: it started as a contingency on 22 Jun 2026, the day the pattern was first recognized at stage 2, four months before the termination notice was actually issued. Bridging stock was already built before the notice period even began. Nothing in the transition was improvised after the decision; the decision only activated a plan that already existed.
Common inspection findings this log prevents
- A relationship pattern that eventually caused a termination, with no record showing when the pattern was first recognized or what oversight change, if any, was tried before escalation.
- Escalation steps taken by email or in meetings with no formal record of the stage, the decision, or the owner.
- A termination notice issued with no evidence a cure period was offered, or with no record of what the cure period actually required.
- Transition-out planning started only after the termination notice, instead of when the risk pattern first appeared, turning a plannable transition into an improvised one.
- No bridging stock built, converting a planned transition into an unplanned shortage.
- A successor site distributing commercial product before the site-change filing was approved.
- Batches or investigations open at the cutover date with no named owner on either side of the termination date.
- Records and raw-data custody never pulled while the outgoing CDMO was still contractually obligated to cooperate, discovered as a gap only after cooperation had already cooled.
- No survival-clause confirmation on file, so the owner’s post-termination audit and record-access rights are asserted rather than verified.
How to adapt this log
- Set your register reference, owner, contract site, and quality agreement reference in the control table.
- Set the escalation timelines in Part A to the actual windows in your quality agreement and escalation SOP; do not leave them generic.
- Keep one issue reference per underlying problem across every stage it reaches in Part B, rather than opening a new reference each time it escalates; the continuity is the point.
- Complete Part D on a defined cadence once a termination notice is issued, not only at the end; a transition tracked only at cutover cannot show whether the plan was actually followed.
- Wire your periodic CDMO performance review (see Report: CDMO Periodic Performance Review) to open or update a Part B entry automatically whenever its decision is anything other than “continue current oversight,” so the escalation trail starts from the metric pattern rather than from a later, harder-to-reconstruct event.
- If the relationship reaches transition-out, run the successor-site technology transfer on Protocol: Technology Transfer to a CDMO, applied in reverse to the new receiving unit.
- Confirm every citation in the references section against the current published version before issue, and confirm the termination mechanics with legal counsel.