This is a ready-to-use form for the mechanics of one specific, narrow obligation inside a broader contract manufacturing relationship: what the contract manufacturing organization (CMO) or contract testing laboratory has to hand over so the marketing authorization holder (MAH) can build a real annual product review / product quality review. It does not replace the quality agreement template, which covers the full responsibility split for batch release, deviations, change control, and audits; this form operationalizes one clause of that agreement into a concrete, dated deliverable checklist both sides can point to. Replace every <<FILL: ...>> placeholder. A worked filled specimen follows. This is general guidance to adapt and verify, not legal advice.
Why this exists as its own document
The most common way a contract manufacturing relationship breaks the product review is not a missing quality agreement clause, it is a vague one. “The Acceptor shall provide data supporting the Giver’s product review” is a sentence a quality agreement can carry for years without anyone noticing it does not specify batch level versus summary level, a deadline, or an audit right, until the year the MAH actually tries to trend the CMO’s numbers and discovers the submission is an unusable paragraph of prose. This form exists to make that obligation concrete, dated, and checkable each cycle, referencing the governing quality agreement rather than restating it.
Document control header
| Field | Entry |
|---|---|
| Document title | CMO/CDMO Product Review Data Contribution |
| Form number | <<FILL: FORM-ID>> |
| Governing quality agreement reference | <<FILL: QA-ID, see the quality agreement template>> |
| Contract giver (MAH) | <<FILL>> |
| Contract acceptor (CMO/CDMO/contract lab) | <<FILL>> |
| Product(s) / activity covered | <<FILL>> |
| Review cycle / period | <<FILL>> |
Part A: What the acceptor compiles and submits
State the required content, granularity, and format for each data category. “Summary” is never an acceptable granularity on its own; a summary may accompany the underlying data but cannot replace it.
| Data category | Required granularity | Format | Applicable? (Y/N/N/A per site’s activity) |
|---|---|---|---|
| Batch disposition (released / rejected / reworked / on hold) for every batch made at the acceptor site in the period | Batch level, every batch, not a count only | <<FILL: extract format, e.g. structured export>> | <<FILL>> |
| In-process and release results for critical quality attributes and critical in-process controls | Result level, every batch | <<FILL>> | <<FILL>> |
| Deviations and non-conformances raised at the acceptor site | Full list, with classification, investigation summary, and closure status per deviation, not a count only | <<FILL>> | <<FILL>> |
| Out-of-specification and out-of-trend results and their investigations | Full list, with root cause and closure status per event | <<FILL>> | <<FILL>> |
| Change controls affecting the product, implemented or approved at the acceptor site in the period | Full list, with change description and validation/revalidation status | <<FILL>> | <<FILL>> |
| Complaints received directly at the acceptor site (where the acceptor has direct-to-site complaint intake) | Full list, forwarded per the complaint-handling agreement timeline | <<FILL>> | <<FILL>> |
| Equipment and utility qualification/requalification status for equipment touching this product | Status summary with dates, overdue items flagged | <<FILL>> | <<FILL>> |
| Material/component incoming rejection data for materials the acceptor sources | Full list, with reasons | <<FILL>> | <<FILL>> |
| Stability data, where the acceptor holds the stability program or a station of it | Result level, by station and time point | <<FILL>> | <<FILL>> |
Fields the MAH is expected to supply itself, and which the acceptor is not required to provide: global field complaints, returns, recalls, marketing authorization variation status, and any cross-site consolidation. Listing these here prevents either party assuming the other is covering them.
Part B: The raw-enough-to-trend requirement
| Requirement | Confirmation |
|---|---|
| Data is provided at batch level or result level, not pre-aggregated into a conclusion (for example “all batches conforming, no significant deviations” is not acceptable on its own) | <<FILL: confirmed / exception noted>> |
| Any narrative summary the acceptor also provides is supplementary to, not a substitute for, the underlying data | <<FILL>> |
| Data arrives in a format the MAH’s statistical tools can ingest without manual re-keying (structured export, not a scanned document) | <<FILL>> |
| Nil results are stated explicitly (for example “zero deviations this period, query run [date] over [period]”), not simply omitted | <<FILL>> |
A submission that fails the raw-enough-to-trend requirement is returned to the acceptor for resubmission before the MAH’s review proceeds to trending; see the data pull reconciliation checklist for the receiving-side check.
Part C: Timing
| Field | Entry |
|---|---|
| Acceptor’s data cutoff (may match or precede the MAH’s overall review cutoff) | <<FILL: date>> |
| Acceptor’s submission deadline | <<FILL: date, must be upstream of the MAH's own review completion deadline>> |
| Lead time built in for the MAH to request clarification or resubmission before the MAH’s own deadline | <<FILL: number of days>> |
| Escalation path if the deadline is missed | <<FILL: who is notified, at what point>> |
Part D: Audit and access rights
| Field | Entry |
|---|---|
| MAH’s right to audit the acceptor’s underlying raw records behind this submission | <<FILL: confirm per the quality agreement clause reference>> |
| Mechanism for verifying submitted numbers against source records (on-site audit, remote data access, or both) | <<FILL>> |
| Frequency of routine audit versus for-cause audit triggered by a discrepancy found in this submission | <<FILL>> |
Part E: Submission record (completed each cycle)
| Field | Entry |
|---|---|
| Cycle / period covered | <<FILL>> |
| Date submitted | <<FILL>> |
| Submitted by (acceptor contact) | <<FILL>> |
| Received by (MAH contact) | <<FILL>> |
| Completeness check against Part A performed | Yes / No, date <<FILL>> |
| Raw-enough-to-trend check against Part B performed | Pass / Fail, if Fail: resubmission requested on <<FILL>> |
| On time against Part C deadline | Yes / No, if No: days late <<FILL>> |
| Discrepancies found against acceptor’s own records (if audited this cycle) | <<FILL: none, or describe>> |
Instructions for use
- Complete Parts A through D once, when the quality agreement is established or renewed, and review them at each quality agreement periodic review.
- Complete Part E fresh every review cycle, as the acceptor’s data contribution actually arrives.
- Treat a Part B failure as a hard stop: return the submission and do not let the MAH’s review proceed to trending on a summary-only contribution, regardless of schedule pressure.
- Where the acceptor also runs its own site-level review of the same batches, keep that site-level review as an internal acceptor record; it is an input to this submission, not a substitute for it, and the MAH’s product-level review still needs the underlying data, not the acceptor’s site-level conclusions. See the contract-manufacturing discussion in the annual product review and PQR article for why this distinction matters at inspection.
- Log every late or incomplete submission across cycles; a pattern of late or thin submissions from one acceptor is itself a supplier-performance signal that belongs in your supplier oversight program.
Retention
| Record | Retention |
|---|---|
| This form (Parts A to D) and each cycle’s Part E submission record | <<FILL: retention period, aligned to the linked APR/PQR report retention>> |
| The underlying data contribution itself | <<FILL: retention period, per the quality agreement and the MAH's product review record retention>> |
Filled specimen
The following shows Parts C and E completed for an illustrative fill-finish CMO relationship. The companies and numbers are illustrative.
Part C: Timing
| Field | Entry |
|---|---|
| Acceptor’s data cutoff | 10 January 2027 |
| Acceptor’s submission deadline | 24 January 2027 |
| Lead time before MAH deadline | 21 days (MAH review due 15 March 2027) |
| Escalation path | Site Quality Head (acceptor) and MAH Contract Quality Lead notified automatically at 5 business days before deadline if not yet submitted |
Part E: Submission record, 2026 annual cycle
| Field | Entry |
|---|---|
| Date submitted | 22 January 2027 |
| Submitted by | M. Alaoui, Site C Quality |
| Received by | R. Osei, MAH APR/PQR Coordinator |
| Completeness check | Yes, 24 Jan 2027, all 9 applicable categories present |
| Raw-enough-to-trend check | Fail on first submission: deviation list arrived as a narrative summary (“3 minor deviations, all closed, no product impact”) rather than a structured list. Resubmission requested 24 Jan 2027, batch-level structured list received 27 Jan 2027, then Pass. |
| On time | Yes, initial submission 2 days ahead of deadline; resubmission absorbed by the 21-day lead time built into Part C |
| Discrepancies found | None; the 3 deviations in the resubmitted list reconciled against the acceptor’s own deviation log during the routine annual audit conducted 10 Feb 2027 |
This is exactly the failure mode Part B exists to catch: a well-intentioned acceptor sent a clean summary on time, and it was still unusable for trending until returned and resubmitted in a structured format, inside the lead time the MAH had deliberately built into the schedule for exactly this situation.
Common inspection findings this form prevents
- A quality agreement that references the product review in one general sentence, with no specification of data granularity, deadline, or audit right, discovered only when the MAH cannot actually trend what the CMO sent.
- The CMO’s own site-level review accepted as if it were the MAH’s product-level review, with no underlying data ever transferred.
- A late CMO submission that was never logged, so a pattern of late data across cycles never surfaces as a supplier-performance issue.
- No mechanism for the MAH to verify a CMO’s submitted numbers against the CMO’s own raw records.
- A summary-only submission accepted under deadline pressure because no lead time was built in for a resubmission cycle.
How to adapt this form
- Set your form number and link it to the specific quality agreement clause it operationalizes.
- Tailor Part A to the actual activities the acceptor performs (drop rows for activities the acceptor does not perform, for example stability where the MAH holds the full program).
- Set the submission deadline in Part C with enough lead time before your own APR/PQR SOP’s completion window to absorb at least one resubmission cycle, as in the specimen.
- Confirm the audit-access language in Part D matches what your quality agreement and the FDA guidance on contract manufacturing quality agreements (2016) actually support.
- Where you manage several CMOs for one product, complete one form per acceptor and consolidate the Part E records into the product-level review per your governing SOP.