Tag: Quality control

Understand the meaning of active substance gases under EudraLex Volume 4 Annex 6, including their manufacture, purification, storage, transfer and the regulatory boundary between active substance and medicinal-product manufacture.

EudraLex Volume 4 – Annex 6 provides specific Good Manufacturing Practice (GMP) requirements for the manufacture of medicinal gases. This article provides an overview of the key aspects, including production, premises and equipment, filling, testing, quality control, documentation, storage, transportation, and traceability.