This is a ready-to-use checklist for bringing a Validation Master Plan current against PIC/S PI 006-4, Recommendation on Qualification and Validation, which enters into force on 1 October 2026 and replaces the four-document PI 006-3 structure dated September 2007. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
Document control header
| Field | Entry |
|---|---|
| Parent VMP document number | <<FILL>> |
| Reviewer | <<FILL>> |
| Review date | <<FILL>> |
Checklist
| # | Item | Pass / Fail / N/A | Evidence / notes |
|---|---|---|---|
| 1 | Reference list no longer cites “PIC/S PI 006-3” or describes it by the old four-document structure (VMP, IQ/OQ, non-sterile process validation, cleaning validation) | <<FILL>> | <<FILL>> |
| 2 | Reference list cites “PIC/S PI 006-4, Recommendation on Qualification and Validation (in force 1 October 2026)“ | <<FILL>> | <<FILL>> |
| 3 | Scope statement addresses performance qualification as its own distinct stage, not folded silently into installation and operational qualification | <<FILL>> | <<FILL>> |
| 4 | Scope statement or inventory register addresses utility qualification specifically, not assumed covered because “facility systems” appears in the scope table | <<FILL>> | <<FILL>> |
| 5 | Scope statement addresses transport verification, if the product ships to any external site | <<FILL>> | <<FILL>> |
| 6 | Scope statement addresses test method validation as its own item | <<FILL>> | <<FILL>> |
| 7 | Risk framework reflects ICH Q9 quality risk management running through the qualification and validation lifecycle, not referenced once and left to the reader to apply | <<FILL>> | <<FILL>> |
| 8 | VMP aligned to the current, 2015 revision of EU Annex 15, consistent with what PI 006-4 itself is built against | <<FILL>> | <<FILL>> |
Disposition
| Field | Entry |
|---|---|
| Overall outcome | <<FILL: VMP current as-is / reference update only / scope update required>> |
| Follow-up actions, if any, with owner and due date | <<FILL>> |
Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Reviewer (Validation) | <<FILL>> | ||
| Approver (Quality Assurance) | <<FILL>> |
Filled specimen
Acme Therapeutics ran this checklist against its VMP in September 2026, folding the review into its regularly scheduled periodic review cycle ahead of the 1 October 2026 effective date.
| # | Item | Result | Evidence / notes |
|---|---|---|---|
| 1 | No stale PI 006-3 citation | Fail | Reference list section 9.3 cited “PIC/S PI 006-3, September 2007” |
| 2 | PI 006-4 cited correctly | Fail, corrected during this review | Updated to “PIC/S PI 006-4, Recommendation on Qualification and Validation (in force 1 October 2026)“ |
| 3 | PQ treated as distinct stage | Pass | VMP section 4 already separates IQ, OQ, and PQ as distinct qualification stages |
| 4 | Utility qualification addressed specifically | Fail, corrected | Scope table previously listed “facility systems” as one line; split into a dedicated utility qualification row covering purified water, clean steam, and compressed gases |
| 5 | Transport verification addressed | N/A | Product does not ship to an external site under this program; noted as an explicit out-of-scope statement with rationale |
| 6 | Test method validation addressed | Pass | Covered under the existing analytical method validation section, cross-referenced |
| 7 | ICH Q9 integrated, not referenced once | Pass | Risk framework applies quality risk management at each qualification stage per section 5 |
| 8 | Aligned to current Annex 15 | Pass | VMP already references the 2015 Annex 15 revision throughout |
Disposition
| Field | Entry |
|---|---|
| Overall outcome | Reference update and scope table correction required; no program-level qualification work missing |
| Follow-up actions | Update reference list (owner: VMP owner, due before 1 October 2026); split utility qualification into its own scope row (owner: VMP owner, due before 1 October 2026) |
Common inspection findings this checklist prevents
- A reference list still citing the superseded PIC/S PI 006-3 or its four-document structure after 1 October 2026, when PI 006-4 is the current recommendation.
- Utility qualification assumed covered under a generic “facility systems” scope line, with no specific statement a PIC/S-trained inspector would recognize as addressing it.
- A VMP’s risk framework that references ICH Q9 once in an introduction with no evidence quality risk management is actually applied at each qualification stage.