# Module 2 — technical source map

Originally checked 26 October 2026; corrected 27 October 2026. Scope: human medicinal products, qualification planning. This is not a complete jurisdiction-specific compliance course.

| Lesson | Primary support | Boundary / teaching choice |
|---|---|---|
| 2.1 Planning | EU GMP Annex 15, General, 1.1–1.8; WHO TRS 1019 Annex 3 §5 | V-201 is fictional; no sterile-process claim. |
| 2.2 VMP | EU Annex 15 §§1.4–1.6; WHO §7 | VMP or equivalent under EU text; outline is illustrative, not a mandatory universal template. |
| 2.3 Boundaries | EU Annex 15 §§1.3, 1.5, 1.7 | Interface/owner examples are an original implementation exercise. |
| 2.4 URS | EU Annex 15 §§3.1–3.3 | Missing range/tolerance intentionally unresolved; never supplied as a universal criterion. |
| 2.5 Traceability | EU Annex 15 §§2.2–2.10, 3.2–3.7 | Matrix is a useful teaching method, not asserted as a universally mandated form. Supplier-test reuse needs justification. |
| 2.6 Risk question | ICH Q9(R1) §§3, 4.2–4.3, 5.1, 5.3 | Fictional causal chain requires scientific evidence in real work. |
| 2.7 FMEA | ICH Q9(R1) Annex I.2–I.3; §§4.3–4.4, 5.3 | Ordinal 1–3 scale is a pedagogical arithmetic exercise; no official threshold. |
| 2.8 Controls | ICH Q9(R1) §§4.4–4.6 | Proposed control is not credited without effectiveness evidence. Risk assessment does not waive requirements. |
| 2.9 Data | WHO TRS 1019 Annex 3 §5.2 (statistical evaluation where appropriate) | Dataset and 0.5 °C limit invented for transparent arithmetic. No capability/qualification conclusion. |
| 2.10 Handover | EU Annex 15 §2.10; ICH Q9(R1) §§4.4–4.6 | Specific-stage progression differs from routine-use authorization. No fabricated signatures. |

Official sources:
- https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en?filename=2015-10_annex15.pdf
- https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en — lists Annex 15 as operational since 1 October 2015. Revision proposals are not treated as adopted text.
- https://database.ich.org/sites/default/files/ICH_Q9(R1)_Guideline_Step4_2022_1219.pdf
- https://www.ema.europa.eu/en/scientific-guidelines/ich-q9-quality-risk-management — current version effective 26 July 2023; corrected publication listed 31 January 2025.
- https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/production/trs1019-annex3-gmp-validation.pdf

No GMP/regulatory approval, certification or independent reviewer acceptance is claimed. The final 80% practice target and capstone rubric are educational choices.


## 27 October recheck
See claude-response-2026-10-27.md for exact official references and corrected scopes: Annex 15 §§1–4 and 11; ICH Q9(R1) §7 and Annex I.2–I.3; WHO main-text §§7–10 and 15. The 2026 Annex 15 concept paper is not operative replacement guidance.