CGA M 2 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
10-16-2023
01-12-2013
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)
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