Regulatory library

EudraLex Volume 4, Chapter 4

Chapter 4 covers documentation. It asks for written procedures and records for equipment use, cleaning, maintenance and calibration, kept so that the history of each piece of equipment can be traced.

ValDoc's library holds 5 provisions of EudraLex Volume 4, Chapter 4. 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.

Last checked

Equipment it reaches

Baseline requirements that cite it

  • Records shall be attributable, legible, contemporaneous, complete and retrievable with controlled corrections and review, using approved paper/electronic/hybrid arrangements.
  • The approved retention schedule shall identify each record class, governing period, accessible format and tested retrieval/archive arrangements throughout the required life.
  • Shipment records shall maintain product/lot or HCT/P identity, custody, dispatch/receipt conditions and documented excursion disposition.
  • and 7 more

Provisions in ValDoc's library

  1. EU GMP Chapter 4 §§4.1–4.6

    Effective JAN2011

    Open the European Commission siteLast checked

  2. EU GMP Chapter 4 §§4.7–4.9

    Effective JAN2011

    Open the European Commission siteLast checked

  3. EU GMP Chapter 4 §§4.10–4.12

    Effective JAN2011

    Open the European Commission siteLast checked

  4. EU GMP Chapter 4 §4.18

    Effective JAN2011

    Open the European Commission siteLast checked

  5. EU GMP Chapter 4 §§4.29–4.31

    Effective JAN2011

    Open the European Commission siteLast checked

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.