ABSTRACT
In their coverage of this topic, the two GMPs dif fer significantly in their approach. In the US cGMPs, after an introductory statement (Section 211.100) of the basic principles that (a) “There shall be written procedures for production and process control …” and that (b) “Written production and process control procedures shall be followed ….” a further series of seven sections (211.101 to 211.115) lay down requirements for the various stages of the overall activity of Production (which in this US context does not include packaging), from “Charge-in of components” to “Reprocessing,” indicating at each stage the written procedures that should be followed.
