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ISO 13408-1:1998

Aseptic processing of health care products -- Part 1: General requirements

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.

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.

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