scope:

This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for the validation and control of aseptically processed health care products.

This part of ISO 13408 includes requirements and guidance relative to the overall topic of aseptic processing.

NOTE Future parts of ISO 13408 will address specialty topics related to aseptic processing, including detailed descriptive information concerning various specialized processes and methods related to filtration, freeze-drying, sterilization in place, cleaning in place, isolator technology, and solid medical devices.

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