FDA Draft Guidance: Current Good Manufacturing Practice for Medical Gases, 6/17

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In June, 2017, the CDER branch of the FDA published Draft Guidance for Industry, Current Good Manufacturing Practice for Medical Gases.  This draft document is intended to aid manufacturers of medical gases in complying with the regulations within 21 CFR Parts 210 and 211.

Medical gases are generally regulated as finished pharmaceuticals and are subject to CGMP requirements.  Compliance with applicable CGMP requirements helps to ensure the safety, identity, strength, quality, and purity of medical gases..

Practices recommended for computer systems include:

• Validation
• Controls for access
• Controls and procedures for changes
• Risk assessments to determine potential impact to product quality, safety, and record integrity
• Audit trails to address risk