Document
DOC 99 / 23 - Good Manufacturing Practice Guide Part II for Medical Gases: Basic Requirements for Active Substances Used as Starting Materials
Download
READ MORE
This publication covers the requirements regarding the manufacturing of the active pharmaceutical ingredients, (API) in Good Manufacturing Practice condition in the field of medicinal gases manufacturing.
In this publication, manufacturing includes all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of active substances and the related controls.