Doc. 99/15/Part 1Good Manufacturing Practice Guide Part I for Medical Gases

Directives from the European Union define the requirements for the “Good Manufacturing Practice” (GMP) of medicinal gases. The purpose of this publication is to provide manufacturers and importers of medicinal gases and fillers of medicinal gas cylinders with a comprehensive guide for the development of a quality management system (QMS) to control their relevant manufacturing processes to meet the GMP requirements. Other requirements for management systems, such as ISO 9001, and may also be used as a guide during pharmaceutical inspections by the national authorities.

  • This EIGA GMP guide is intended for use by all manufacturers of medicinal gases and fillers of medicinal gas cylinders. It covers the:manufacture and storage of all medicinal gases on licensed gas company premises;
  • filling of medicinal gas cylinders; and
  • distribution of bulk medicinal gases and medicinal gas cylinders.

It specifies the requirements necessary to meet the specifications set in the relevant Pharmacopoeia standards and, where required by the national authorities, in the relevant marketing authorisations.

It currently does not cover the specific requirements detailed in:

  • Annex 15, Qualification and validation;
  • Annex 16, Certification by a qualified person and batch release;
  • Annex 17, Parametric release;
  • GMP Part II, Basic requirements for active substances used as starting material; and
  • GMP Part III, Site master file.

Certain national authorities define some of the medical gases that do not fall strictly under the definition of a medicinal product, as medical device gases.

These gases, normally used in conjunction with medical devices, do not strictly fall under the control of the EC GMP guide, but for the purposes of this document can be considered in the same way as for other medicinal gases;

Within the text, any reference to the manufacture, filling, storage or distribution of medicinal gases shall apply equally to any medical device gases.