Publication
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.
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Edition:
2
Published:
August 2015
Status:
Available To the Public
Size:
1 pages
Publisher:
CGA
Special Attributes:
Notes:
Committee:
Medical Gases
Keywords
Related
M-7