# Technical source map — checked 31 October 2026

Official operative-source index: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en

| Lesson | Pinpoint reference | Teaching scope |
|---|---|---|
| 3.1 | Annex 15 §3.3, §§3.8–3.14, DQ glossary | Design conclusion versus later qualification |
| 3.2 | Annex 15 §§3.2–3.3; Chapter 4 §§4.1–4.5 | Requirements and controlled document baseline |
| 3.3 | Annex 15 §§3.2–3.3; Chapter 3 §§3.40–3.41 | Measurement requirements and later verification |
| 3.4 | Chapter 3 §§3.34–3.39; Annex 15 §§3.3, 10.1 | Suitability, cleanability, contact materials and later cleaning validation |
| 3.5 | Annex 15 Principle, §3.3; Annex 11 §§4, 7, 9–10, 12 | Controls, records and computerized-system interface |
| 3.6 | Chapter 3 §§3.34–3.38; Annex 15 §§3.3, 3.9 | Maintenance access, installation and utility interfaces |
| 3.7 | Annex 15 §§1.7–1.8, 3.2 | Risk and evidence integrity |
| 3.8 | Annex 15 §§2.6, 3.4–3.7 | Supplier evidence suitability and justified reuse |
| 3.9 | Annex 15 §2.10, §11; Chapter 4 §4.5 | Defined next stage, documented impact and controlled change |
| 3.10 | Annex 15 §§2.10, 3.3, 3.9 | Scoped conclusions and qualification handover |

Annex 15: https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en
Chapter 3: https://health.ec.europa.eu/document/download/18d76565-137b-41d2-a602-794527f708c1_en?filename=chapter_3.pdf
Chapter 4: https://health.ec.europa.eu/document/download/104b3eb8-81a7-4858-9419-cb06562adb66_en?filename=chapter4_01-2011_en.pdf
Annex 11: https://health.ec.europa.eu/document/download/8d305550-dd22-4dad-8463-2ddb4a1345f1_en?filename=annex11_01-2011_en.pdf

Chapter 3 §§3.37–3.41 and Chapter 4 §§4.1–4.5 were read in the official PDFs, resolving the AI review's unverified pinpoint references. The index lists the adopted 2015 Annex 15 and 2011 Annex 11; consultation material is not substituted for adopted guidance.

V-201 specifications, diagrams, criteria and calculations are fictional teaching examples. The ±0.5 °C tolerance is not a regulatory limit. Conservative worst-case addition is not a complete uncertainty budget; alternative combination methods require justified assumptions. The 85% practice target and 80% evidence coverage are separate teaching quantities; neither establishes GMP acceptance. FDA 21 CFR Part 11 applicability requires separate jurisdiction-specific assessment; this module does not demonstrate compliance with it or Annex 11.