DIN EN ISO 13408-1
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013) (includes Amendment A1:2013)
|Publication Date:||1 August 2013|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
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-processe
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.