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CGA M 2 : 2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

GENERAL GUIDE FOR THE MANUFACTURER OF MEDICAL GASES CLASSIFIED AS DRUGS

Superseded date

16-10-2023

Published date

12-01-2013

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.

DocumentType
Standard
PublisherName
Compressed Gas Association
Status
Superseded
SupersededBy

CGA M 5 : 2013 GUIDE FOR HOME RESPIRATORY CARE FIRMS FILLING OR DISTRIBUTING LIQUID OXYGEN USP

CGA M 5 : 2013 GUIDE FOR HOME RESPIRATORY CARE FIRMS FILLING OR DISTRIBUTING LIQUID OXYGEN USP
CGA C 7 : 2014 GUIDE TO CLASSIFICATION AND LABELING OF COMPRESSED GASES

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