Regulatory library

EudraLex Volume 4, Part IV

Part IV is the GMP guide specific to advanced therapy medicinal products. It applies its own risk-based rules on premises, equipment and qualification in place of Annex 2.

ValDoc's library holds 1 provision of EudraLex Volume 4, Part IV. This page is guidance in our words. The regulation's own text governs.

Last updated

Thirty minutes. Bring one piece of equipment.

Provisions in ValDoc's library

  1. EudraLex Volume 4, Part IV (ATMP GMP)

    Effective

    Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

    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.