FDA Draft Guidance for Industry Current Good Manufacturing Practice

In August of 2016 the FDA released Draft Guidance for Industry Current Good Manufacturing Practice.  I have written previously that AFIA submitted 13 pages of comments on the 36 page document and that I was reluctant to discuss this draft document because of some of the  things it contains.  It is a year later and the compliance deadline is upon us (September 2017) but the guidance is still in draft form! It does not look like anything will change so it is time to move on…

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