Standard: AAMI - 13408-1

ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS

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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.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: 13408-1
Publish Date: 2008-01-01
Page Count: 76
Change Type: AMD
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
13408-1 AMD 1 Change Type: STCH Update Date: 2013-01-01 Status: INAC
13408-1 Change Type: STCH Update Date: 2008-01-01 Status: INAC
13408-1 Change Type: Update Date: 2008-01-01 Status: INAC

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