SS-EN-ISO-13408-1 › Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
Active implantable medical devices. Medical devices. In vitro diagnostic medical devices
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
SS-EN ISO 13408-1:2015
July 6, 2015
EN ISO 13408-1:2015(IDT); ISO 13408-1:2008(IDT)