Publication Details

[M-9] Guideline for Maintaining Bulk Gas Supplier Fingerprint Analysis at Compressed Medical Gas Filling Facilities


This publication provides criteria that medical gas subsequent manufacturers can use to satisfy FDA’s fingerprinting concerns. It applies to the procurement of bulk medical gas by subsequent manufacturers and the requirement that bulk carbon dioxide suppliers provide appropriate certification regarding their product’s compliance to current good manufacturing practices (CGMP) and USP specifications.


Category Medical Gases     Standards & Guidelines
Keywords medical gases  |  transfilling
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