This is a ready-to-use readiness checklist for the process validation content of a CTD Module 3 filing, sections 3.2.S.2.5 and 3.2.P.3.5. Run it before the sections go to final QA and regulatory sign-off. Replace every <<FILL: ...>> placeholder with your own specifics. A worked filled specimen follows.
Document control header
| Field | Entry |
|---|---|
| Document title | Filing Readiness Checklist for <<FILL: product, submission type and number>> |
| Document number | <<FILL>> |
| Version | <<FILL>> |
| Review date | <<FILL>> |
| Reviewer(s) | <<FILL>> |
Purpose
This checklist confirms that 3.2.S.2.5 and 3.2.P.3.5 state the validation approach, the batch-count rationale, and the PPQ conclusion clearly enough for a reviewer to follow in a single pass, before the sections are finalized for submission.
Scope
Applies to <<FILL: submission type, e.g. original BLA, supplement>> for <<FILL: product>>.
Checklist items
| Item | Pass / Fail / N/A | Reference |
|---|---|---|
| The validation approach (traditional, continuous process verification, or hybrid) is stated in the first paragraph of both S.2.5 and P.3.5, not implied by a table | <<FILL>> | <<FILL>> |
| The number of PPQ batches is stated explicitly with a documented rationale tied to process characterization | <<FILL>> | <<FILL>> |
| Where the batch count is lower than the traditional three-lot norm, the rationale cites the applicable FDA CMC flexibility guidance and the specific product constraint it addresses | <<FILL>> | <<FILL>> |
| CPP and CQA names and numbering match across S.2.5, P.3.5, P.2, S.2.6, and every other section of Module 3 that references them | <<FILL>> | <<FILL>> |
| A single master PPQ summary table exists, spanning every batch, with acceptance criteria stated once | <<FILL>> | <<FILL>> |
| Every PPQ deviation or OOS result is disclosed in the narrative, with resolution and impact assessment, not left in a footnote or appendix alone | <<FILL>> | <<FILL>> |
| The statistical basis of every pass claim (capability index, tolerance interval, or simple pass/fail) is stated explicitly, not implied by the word “passed” | <<FILL>> | <<FILL>> |
| The Stage 3 continued process verification commitment is written out: what is monitored, at what frequency, escalating to what action | <<FILL>> | <<FILL>> |
| Internal operating ranges (site SOPs, batch records) have been reconciled against the ranges as filed | <<FILL>> | <<FILL>> |
| The Stage 3 CPV program described in the filing actually exists and is producing the trending it promised, confirmed before submission, not assumed | <<FILL>> | <<FILL>> |
| Any comparability claim states its risk basis and residual risk explicitly, not as a bare conclusion | <<FILL>> | <<FILL>> |
| Phase-appropriate honesty check: nothing in the narrative implies more certainty than the underlying data supports; open items are stated as commitments with timelines | <<FILL>> | <<FILL>> |
| The anticipated-questions log from authoring has been checked against the final text | <<FILL>> | <<FILL>> |
Instructions
Complete every row before the section is sent for final QA and regulatory sign-off. A “Fail” on any item is resolved in the text before submission, not carried forward as a known gap; a “N/A” is justified in the reference column, not left blank.
Retention
Retain with the submission’s internal regulatory file per <<FILL: site document retention procedure>>, alongside the anticipated-questions log and the underlying validation reports referenced in the narrative.
Filled specimen
Extract for an example BLA S.2.5 review, cell therapy product. Company and product are illustrative.
| Item | Result |
|---|---|
| Validation approach stated in first paragraph | Pass, traditional PV with 2 PPQ batches stated in the first sentence of S.2.5 |
| Batch count rationale | Pass, tied to the total number of qualified apheresis-matched batches available at commercial scale, with residual risk addressed through enhanced characterization |
| Flexibility guidance cited | Pass, cites the 2026 FDA CMC flexibility guidance and the specific starting-material constraint |
| CPP/CQA naming consistent | Fail on first review, “viable cell dose” in P.3.5 named “cell viability at release” in one table; corrected before resubmission internally |
| Master PPQ summary table | Pass |
| PPQ deviation disclosed | Pass, one minor compression-adjacent event (analogous cell-processing hold-time deviation) disclosed and resolved in text |
| Statistical basis stated | Pass, tolerance-interval basis stated for potency, simple pass/fail stated for sterility |
| Stage 3 CPV commitment written out | Pass |
| Internal ranges reconciled | Pass, confirmed against current batch record revision |
| Comparability risk basis stated | N/A, no comparability claim in this submission |
Common findings this checklist prevents
- A validation approach the reviewer has to infer from a table rather than read in the opening sentence.
- A batch count with no stated rationale, or one that ignores current guidance flexibility that would have supported the number chosen.
- CPP or CQA naming drift between sections, discovered by the reviewer instead of caught internally.
- A Stage 3 CPV commitment that reads well on paper but does not exist in practice at the time of a pre-approval inspection.
How to adapt this checklist
- Set the document number and review date, and assign a named reviewer independent of the section’s author.
- Add product-specific items if your program has a known recurring gap, for example a specific analytical method transfer status.
- Route every “Fail” to resolution before the section leaves for QA and regulatory sign-off; do not submit with an open Fail.