CGA M 3 : 2015

1 Introduction
2 Scope
3 Definitions
4 Health and safety considerations
5 Key laws, regulations, and guidelines
6 Standard operating procedures
7 Organization/Personnel (21 CFR Part 211 Subpart B)
8 Buildings and facilities (21 CFR Part 211 Subpart C)
9 Equipment (21 CFR Subpart D)
10 Control of components and drug product containers and
   closures (21 CFR Subpart E)
11 Production and process controls (21 CFR Subpart F)
12 Packaging and label controls (21 CFR Subpart G)
13 Handling and distribution (21 CFR Subpart H)
14 Laboratory controls (21 CFR Subpart I)
15 Records and reports (21 CFR Subpart J)
16 Returned and salvaged drug products (21 CFR Subpart K)
17 References

Describes the requirements and describes industry standards and positions in meeting the requirements of the Current Good Manufacturing Practices 21 CFR Parts 210 and 211.