ABSTRACT
In this chapter there will, inevitably, be a certain amount of repetition of, or back reference to, material that has already appeared in earlier chapters of this book. This is a consequence of US cGMPs Subpart J (upon which this chapter is based) being, in large part, a recapitulation from a different angle of material that has appeared in earlier subparts (for example, Subparts E, F, G, H, and I).
