Doc. 99/17/Part 2Good Manufacturing Practice Guide Part II for Medical Gases: Basic Requirements for Active Substances Used as Starting Materials

According to Article 46 (f) of Directive 2001/83/EC as amended by Directive 2004/27/EC of the European Parliament on the Community code relating to medicinal products for human use and Article 50 (f) of Directive 2001/82/EC; as amended by Directive 2004/28/EC on the Community code relating to veterinary medicinal products, the manufacturing authorisation holders shall use only active substances that have been manufactured in accordance with Good Manufacturing Practice (GMP) for starting materials.

These guidelines cover the requirements regarding the manufacturing of the active pharmaceutical ingredients, (API) under Good Manufacturing Practice conditions 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.

This publication is intended to provide guidance regarding Good Manufacturing Practice for the manufacture of active substances used in the manufacturing of medicinal gases and mixture and is intended to be used by all those involved in the production of medical gases.