J
agree. Also, keep in mind there is no "one size fits all" management review process. FDA auditors, and very likely others, too, adjust their expectations towards the frequency, scope and formality of GMP-compliant management review along company- or establishment-specific factors. These factors include company size and scope, product complexity, product risk and health risks. Also, the requirement for documented inputs may be implicit. This is the case in the GMP arena. I do not know whether it is true for ISO, too.
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