SS-EN-ISO-13408-1 › Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
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This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes 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.
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Designation Name
SS-EN ISO 13408-1:2015
Revision Level
2015 EDITION
Status
Current
Publication Date
July 8, 2015
Language(s)
English
Page Count
72
International Equivalent
EN ISO 13408-1:2015(IDT); ISO 13408-1:2008(IDT)