FDA Medical Gases Reference Materials - April 2009

 

TOPIC TAB
 Acknowledgement - List of Committee Members   
Table of Contents 1
Overview 2
Registration / Listing 3
Standard Operating Procedures 4
Draft Guidance for Industry on the Current Good Manufacturing Practice for Medical Gases 5
Addresses / Contacts 6
Electronic Records 21 CFR Part 11 7
Gas Specifications 8
[reserved for future use] N/A
"Fresh Air 2000" 10
Current Good Manufacturing Practice 11

This information was developed to assist GAWDA members in complying with government regulations; it does not constitute legal advice, and users are advised to obtain legal counsel to develop their individual compliance programs Additionally, GAWDA does not guarantee that use of this material will ensure compliance with any regulatory or legal standard. GAWDA (25 March 2009)

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