CGA M 2 : 2013

1 Introduction
2 Scope
3 Definitions
4 Health and safety considerations
5 Key laws, regulations, and guidelines
6 Standard operating procedures
7 Organization and Personnel (21 CFR 211 Subpart B)
8 Buildings and Facilities (21 CFR 211 Subpart C)
9 Equipment (21 CFR 211 Subpart D)
10 Control of Components (21 CFR 211 Subpart E)
11 Control of Containers and Closures (21 CFR Part 211
   Subpart E)
12 Production and Process Controls (21 CFR Part 211
   Subpart F)
13 Packaging and Label Controls (21 CFR Part 211
   Subpart G)
14 Holding and distribution of finished product (21 CFR
   Part 211 Subpart H)
15 Laboratory Controls (21 CFR Part 211 Subpart I)
16 Records and Reports (21 CFR Part 211 Subpart J)
17 Returned and Salvaged Drug Products (21 CFR Part 211
   Subpart K)
18 References
19 Additional references
Appendix
Appendix A - Typical high pressure oxygen fill
             record (Informative)

Applies to firms that engage in the filling, repackaging, transfilling, mixing, and/or relabeling of compressed medical gases (CMG) that are classified as drugs by the U.S. Food and Drug Administration (FDA) and applicable state agencies.