Regulatory library

EudraLex Volume 4, Chapter 5

Chapter 5 covers production. It asks that equipment be cleaned and checked before use and that cross-contamination between products be prevented.

ValDoc's library holds 2 provisions of EudraLex Volume 4, Chapter 5. It can apply to URSs for 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.

Equipment it reaches

Baseline requirements that cite it

  • The design shall prevent harmful migration of pump oil, condensate, coolant or contaminants into the product/process path during operation and foreseeable shutdown conditions.

Provisions in ValDoc's library

  1. EU GMP Chapter 5 §§5.19–5.21

    Effective

    Open the European Commission siteLast checked

  2. EU GMP Chapter 5 §5.22

    Effective

    Open the European Commission site

Other regulations

Every regulation in ValDoc's library

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.