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VOL. 2, ISSUE 6 (2017)
Overview of regulatory requirements for medical gases and pharmaceutical gases
Authors
Navdha Soni, Dr. Dilip G Maheshwari
Abstract
Generally medical gases are administered or supplied directly to the patients. They should be monitored as required by the respective regulatory authorities of every country or via a central line which runs through the entire hospital. They should be manufactured and transferred with the highest quality possible as per standards and limits decided by the different regulatory authorities. For the manufacturing of the medical gases manufacturer needs to issue license (or regulatory approval) hence they justify about maintaining quality of the gases as standard/limitation regarding quality decided by the drug regulatory authorities.
Pharmaceutical gases is defined as gaseous material that are manufactured for the use in pharmaceutical industries and laboratories and used in Process/Quality Control and R&D for hydrogenation process, reactors, analytical instruments etc. They are needed to handle under the standards with which they are governed are strictly controlled by a nation's pharmacological oversight agency.
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Pages:61-64
How to cite this article:
Navdha Soni, Dr. Dilip G Maheshwari "Overview of regulatory requirements for medical gases and pharmaceutical gases". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 2, Issue 6, 2017, Pages 61-64
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