AAMI 13408-1

Aseptic processing of health care products - Part 1: General requirements

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Organization: AAMI
Publication Date: 1 January 2008
Status: active
Page Count: 79
scope:

This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

NOTE This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regional jurisdictions.

Document History

January 1, 2013
Aseptic processing of health care products - Part 1: General requirements Amendment 1
A description is not available for this item.
AAMI 13408-1
January 1, 2008
Aseptic processing of health care products - Part 1: General requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process...
January 1, 2008
Aseptic processing of health care products — Part 1: General requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process...
January 1, 2008
Aseptic processing of health care products - Part 1: General requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process...
January 1, 2008
Aseptic processing of health care products — Part 1: General requirements
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process...

References

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