Regulatory library
EudraLex Volume 4, Annex 19
Annex 19 covers reference and retention samples, including storage conditions for them that are controlled and recorded.
ValDoc's library holds 3 provisions of EudraLex Volume 4, Annex 19. It can apply to URSs for controlled temperature units, depending on their intended use. This page is guidance in our words. The regulation's own text governs.
Last updated
Thirty minutes. Bring one piece of equipment.
Equipment it reaches
Baseline requirements that cite it
- The storage configuration shall preserve required material identity, segregation and assigned storage conditions with traceable location records.
Provisions in ValDoc's library
EU GMP Annex 19 §§3–5 (2026 revision)
Effective
Open the European Commission siteLast checkedEU GMP Annex 19 (2026 revision) §§2.4, 3, 4.4, 5-6
Effective
EU GMP Annex 19 (2026 revision) §9
Effective
Other regulations
- ATEX Directive 2014/34/EU
- Directive 2000/54/EC
- EMA GMP questions and answers: nonsterile manufacture
- EMA Guideline on process validation for finished products
- EU GDP Guidelines 2013/C 343/01
- EudraLex Volume 4
- EudraLex Volume 4, Annex 1
- EudraLex Volume 4, Annex 2
- EudraLex Volume 4, Annex 11
See your own equipment in ValDoc.
Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.
Thirty minutes. Bring one piece of equipment.