This is a ready-to-use readiness review checklist for a Process Performance Qualification (PPQ) campaign, built around the thirteen prerequisites that decide PPQ success before batch one. Every row requires a document reference and a date, not a verbal confirmation collected in the review meeting itself; an item with no evidence reference is not closed, regardless of how confident the room feels. Replace every <<FILL: ...>> placeholder with your own specifics and route this through your normal document control, review, and approval. A worked filled specimen follows.
Document control header
| Field | Entry |
|---|---|
| Document title | PPQ Readiness Review Checklist for <<FILL: product / process>> |
| Document number | <<FILL: e.g. CHK-PPQ-004>> |
| Version | <<FILL>> |
| Review date | <<FILL>> |
| Linked PPQ protocol | <<FILL: ref>> |
| Review facilitator | <<FILL: e.g. Validation Lead>> |
1. Purpose
This checklist confirms, with dated documentary evidence, that every prerequisite for a defensible PPQ campaign is closed before the PPQ protocol is approved and before batch one is scheduled to run. It is a gate, not a status update: any item scored “Not closed” blocks protocol approval until it is either closed or formally risk-accepted by Quality Assurance in writing.
2. Scope
| Dimension | Decision |
|---|---|
| Product / process in scope | <<FILL>> |
| PPQ protocol under readiness review | <<FILL: ref and version>> |
| Manufacturing site(s) | <<FILL: internal site or CDMO name>> |
| Out of scope | <<FILL: e.g. commercial launch readiness beyond PPQ itself>> |
3. Responsibilities
| Role | Responsibility |
|---|---|
| Validation lead | Facilitates the review, owns this checklist, confirms every evidence reference actually exists and is dated before batch one |
| Process development / manufacturing science | Confirms process characterization, CPP/CQA locking, and hold-time evidence |
| Statistics | Confirms the batch-count risk basis and the sampling plan’s statistical basis |
| Analytical / QC | Confirms method validation and transfer closure |
| Manufacturing / site operations | Confirms the batch record’s frozen, effective status |
| CDMO relationship owner or person-in-plant lead | Confirms the four CDMO logistics checks, where applicable |
| Quality Assurance | Approves the checklist and the PPQ protocol only once every item is closed or formally risk-accepted |
4. Readiness checklist
Score each item Closed, Not Closed, or N/A. A “Closed” score requires an evidence reference with a date that precedes today’s review; a verbal assurance is not evidence.
| # | Prerequisite | Objective evidence required | Evidence reference | Date | Owner | Score |
|---|---|---|---|---|---|---|
| 1 | Process characterization | Every CPP range in the protocol traces to a specific Stage 1 study; control strategy closed and approved | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 2 | CPPs and CQAs locked | Stable and approved for a defined period; no open investigations against them | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 3 | Hold-time strategy | A dedicated worst-case study exists and passed for every hold step in the batch record | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 4 | Batch size and bracketing | Matches the commercial supply plan; any bracket’s extremes and at least one midpoint have supporting data | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 5 | Batch count and sampling | Batch count traces to a written risk assessment; every sampling point states its statistical basis, confidence, and coverage | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 6 | Analytical methods | Method validation reports approved; method transfer closed where applicable | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 7 | Batch records | Approved, effective, and unchanged for the campaign; version matches the version cited in the protocol | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 8a | CDMO: transfer report | Closed and approved, not “substantially complete” | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 8b | CDMO: comparability | Established with data between sending and receiving sites | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 8c | CDMO: material release | Raw materials, including long-lead or single-source items, released with margin | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 8d | CDMO: facility fit | Equipment train, environmental classification, and utilities assessed and closed | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 9 | Facility and aseptic readiness (sterile products only) | Media fill current and passing for the specific line, shift, and configuration PPQ will run on; environmental monitoring shows no unresolved adverse trend; operator gowning qualification current | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 10 | Deviation criticality classification | Classification criteria for deviations arising during the campaign written and approved, with a stated conservative default for uncertain cases | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 11 | Personnel and training readiness | Every scheduled operator and analyst holds a dated training record for the exact approved batch record version, not just the general unit operation or method | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 12 | Raw material and single-source risk | Single-source and long-lead materials inventoried; replacement lead time compared against schedule margin; a documented, triggered contingency exists for every flagged item | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 13 | Protocol amendment procedure defined | A documented procedure exists for distinguishing a deviation from a protocol amendment and routing a mid-campaign amendment through the same approval chain as the original protocol | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
5. Disposition of open items
Any item scored “Not Closed” above must appear here with a decision, not be carried silently into the protocol approval.
| Item # | Gap | Decision: close before batch one / move the date / documented risk acceptance | Approved by | Date |
|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
6. Overall disposition
| Field | Entry |
|---|---|
| Total items closed | <<FILL>> of 16 |
| Items open with a documented risk acceptance | <<FILL>> |
| Items open with no disposition (blocks approval) | <<FILL>> |
| Recommendation | Approve PPQ protocol for execution / Hold pending closure of item(s) <<FILL>> |
| QA decision | <<FILL>> |
7. References
FDA guidance, “Process Validation: General Principles and Practices” (January 2011). EU GMP Annex 15, Qualification and Validation. See the paired article, PPQ readiness: the prerequisites that decide success before batch one, for the reasoning behind each row. The paired PPQ personnel and training qualification verification record, single-source and long-lead raw material contingency plan, and PPQ protocol amendment justification form for the evidence behind rows 11 through 13.
8. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
9. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Facilitator (Validation) | <<FILL>> | ||
| Reviewer (Quality Assurance) | <<FILL>> |
Filled specimen
Extract for an example monoclonal antibody drug substance process transferring into a CDMO for commercial PPQ. Company and product are illustrative.
| # | Prerequisite | Evidence reference | Date | Score |
|---|---|---|---|---|
| 1 | Process characterization | Stage 1 Characterization Report CHR-014, v2.0 | 2026-06-30 | Closed |
| 2 | CPPs and CQAs locked | Control Strategy Summary CSS-009, approved, no open investigations | 2026-07-10 | Closed |
| 3 | Hold-time strategy | Hold-Time Study Report HTS-021 (harvest-to-purification hold, 48h worst case) | 2026-07-18 | Closed |
| 4 | Batch size and bracketing | Supply Plan v4 confirms 2000 L as commercial scale; matches protocol | 2026-06-15 | Closed |
| 5 | Batch count and sampling | Batch Count Risk Assessment RA-PPQ-009 (3 batches); Sampling Plan Statistical Basis SPB-006 | 2026-08-01 | Closed |
| 6 | Analytical methods | Method Validation Summary MVS-011; Method Transfer Report MTR-004 (both closed) | 2026-07-25 | Closed |
| 7 | Batch records | Master Batch Record MBR-PPQ-003, v3.0, effective | 2026-08-05 | Closed |
| 8a | CDMO transfer report | Technology Transfer Report TTR-018, approved | 2026-07-28 | Closed |
| 8b | CDMO comparability | Site Comparability Report SCR-007 (3 engineering batches vs. sending-site history) | 2026-08-02 | Closed |
| 8c | CDMO material release | Resin lot released with 6-week margin against a single-source dependency flagged in the risk assessment | 2026-08-08 | Closed |
| 8d | CDMO facility fit | Facility Fit Assessment FFA-005, closed with one open action (see disposition below) | 2026-07-20 | Not Closed |
| 9 | Facility and aseptic readiness | Media Fill Report MF-2026-014 (line 2, shift A, passing, within its 6-month qualified interval); EM Trend Report EMT-Q3-2026 shows no unresolved adverse trend | 2026-08-10 | Closed |
| 10 | Deviation criticality classification | Deviation Criticality Pre-Classification Plan PLN-DEV-005, approved | 2026-08-04 | Closed |
| 11 | Personnel and training readiness | PPQ Personnel and Training Qualification Verification Record TRN-PPQ-021, all scheduled operators and analysts closed | 2026-09-19 | Closed |
| 12 | Raw material and single-source risk | Single-Source and Long-Lead Raw Material Contingency Plan PLN-RM-008; one item (Protein A resin) required a slot move rather than a contingency, reflected in section 5 below | 2026-07-05 | Closed |
| 13 | Protocol amendment procedure defined | PPQ Protocol Amendment Justification Form procedure referenced in the site’s validation SOP, confirmed applicable to this campaign | 2026-08-01 | Closed |
Disposition of open items: item 8d, a facility-fit action confirming a backup chromatography skid’s qualification status, was still open with 10 days of schedule margin remaining before the booked CDMO slot. QA and the CDMO relationship owner agreed to close the action before batch one rather than accept it as residual risk, since margin existed to do so; the action closed 3 days before batch one with documented evidence. Item 12’s underlying contingency plan had flagged the Protein A resin’s 14-week replacement lead time against only 10 weeks of schedule margin; rather than accept that gap, the booked CDMO slot was moved 5 weeks before this checklist was finalized, restoring margin, so item 12 itself closed Closed with no open disposition carried forward. The checklist was updated to reflect 16 of 16 items closed before the protocol was approved for execution.
Common inspection findings this checklist prevents
- A readiness review that reaches a verbal consensus with no documentary evidence behind individual items.
- An open item carried into batch one with no recorded decision to close it, move the date, or formally accept the risk.
- A facility-fit or material-release gap discovered only after batch one starts, because CDMO logistics were never scored as their own readiness items.
- A PPQ protocol approved by QA with no record of what, specifically, QA reviewed before approving.
How to adapt this checklist
- Set your document number, product, and linked protocol reference in the header.
- Confirm the evidence reference for every row is a real, dated document, not a placeholder description of one.
- Route every “Not Closed” item through section 5 before the protocol is approved; never let an open item pass silently into execution.
- If your process spans multiple sites or a bracketed family of presentations, duplicate rows 1 through 7 per site or bracket member rather than scoring them once for the whole family.
- Confirm the references in section 7 against the current published version before issue.