CGA M 7 : 2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STANDARD FOR QUALIFYING SUPPLIERS USED BY MEDICAL GAS MANUFACTURERS, EQUIPMENT MANUFACTURERS, AND DISTRIBUTORS
10-12-2022
12-01-2013
1 Introduction
2 Scope
3 Definitions
4 Product, component, and service assessment
5 Supplier qualification
6 Records
7 References
Appendices
Appendix A - Example of a numerical critical ranking system
(Informative)
Appendix B - Example of a CGMP checklist for drugs - 21 CFR
Part 211 [4] (Informative)
Appendix C - Example of a competitor supplier qualification
form (original manufacturer to provide to another
original manufacturer or subsequent manufacturer)
(Informative)
Appendix D - Example of a competitor supplier qualification
form (subsequent manufacturer to provide to
another subsequent manufacturer or wholesaler
(Informative)
Appendix E - Example of an CGMP checklist for suppliers
of finished medical devices - 21 CFR Part 820 [4]
(Informative)
Appendix F - Example of a supplier quality checklist for
suppliers for parts or services excluding suppliers
of finished medical devices (Informative)
Appendix G - Example of an audit agenda (Informative)
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