Regulatory library
EudraLex Volume 4, Chapter 6
Chapter 6 covers quality control. It asks that laboratory equipment be qualified and calibrated and that test data be recorded and reviewed.
ValDoc's library holds 3 provisions of EudraLex Volume 4, Chapter 6. It can apply to URSs for environmental monitoring, 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 data workflow shall allow trend review and traceable investigation of excursions, including instrument status and calibration impact.
- The sampler shall deliver the specified sampling conditions without compromising the approved sampling method or sample identity.
Provisions in ValDoc's library
EU GMP Chapter 6 §§6.5–6.7
Effective
EU GMP Chapter 6 §§6.8–6.10
Effective
Open the European Commission siteLast checkedEU GMP Chapter 6 §§6.11–6.12
Effective
Open the European Commission siteLast checked
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.