Full Description

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.

Product Details

Edition: 2nd Published: 08/01/2015 Number of Pages: 8 File Size: 1 file , 140 KB