ANSI AAMI ISO 13408-1-2008 (R2017) A1-2013 (R2017)

Category: Technical

Posted on 2020-09-14, by banz.


Aseptic Processing Of Health Care Products -- Part 1: General Requirements (Includes Amendment 1). Specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process for aseptically processed health care products. The included amendment corrects spelling errors; clarifies a definition note; and replaces terms used in Table 1 and Table 2.

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