CGA P-8.2 provides the Compressed Gas Association (CGA) position and guidance on the manufacturing, bulk product storage, and cargo transport unit filling validation activities that take place at a typical air separation unit (ASU) that is manufacturing medical oxygen, medical nitrogen, or both. Variations from the typical ASU process configurations can exist. Companies shall assess variations and determine if deviations from this guidance are necessary.

The approach and activities in this publication are designed to ensure that these gases, which are classified as drug products, have the claimed identity, strength, quality, and purity. Scientific, documented studies will show that the given utility, system, process, or piece of equipment:

• meets the specifications of its design for its critical elements;
• is properly installed, operated, and maintained;
• is suitable for its intended application;
• is in accordance with principles established and generally accepted by the compressed gas industry;
• meets the current good manufacturing practices (CGMP)/good manufacturing practices (GMP) requirements;
• meets the principles of FDA’s Guidance for Industry, Process Validation General Principles and Practices, and meets the Health Canada Validation Guidelines for Pharmaceutical Dosage Forms (GUIDE-0029); and
• is capable of consistently producing a product that meets all predetermined specifications and quality attributes.

This publication addresses validation for ASU cryogenic manufacturing and cargo transport unit filling processes pertaining to medical oxygen and medical nitrogen.