Regulatory library
EudraLex Volume 4, Chapter 3
Chapter 3 covers premises and equipment. It asks that equipment be designed, located and maintained to suit its operations, be easy to clean, not affect the product, and that measuring instruments be calibrated.
ValDoc's library holds 6 provisions of EudraLex Volume 4, Chapter 3. It can apply to URSs for biosafety cabinets, centrifuges, cryogenic systems, controlled temperature units, environmental monitoring, incubators, label printers, stability chambers, sterilization equipment, transport systems, thermal sealing and welding systems and vacuum pumps, 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.
Baseline requirements that cite it
- The equipment shall perform the approved intended use over the specified capacity and operating envelope, with installation access for cleaning, inspection and maintenance.
- The design shall identify product-contact and potential indirect-contact materials and prevent unacceptable contamination from surfaces, seals, lubricants and utilities.
- The cabinet shall accommodate the specified operations, working envelope and approved installation location while supporting cleaning and maintenance.
- and 20 more
Provisions in ValDoc's library
EU GMP Chapter 3 §§3.34–3.39
Effective
Open the European Commission siteLast checkedEU GMP Chapter 3 §§3.40–3.41
Effective
Open the European Commission siteLast checkedEU GMP Chapter 3 §§3.42–3.44
Effective
EU GMP Chapter 3 §§3.3,3.12,3.19
Effective
Open the European Commission siteLast checkedEU GMP Chapter 3 §3.6
Effective
EU GMP Chapter 3 §3.19
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.