Per PIC/S GMP Chapter 6: quality control. Requirements include (a) implement Quality Control independent from production with separate authority + (b) implement Quality Control Testing including raw materials + intermediates + finished products + stability + environmental monitoring + (c) implement Quality Control and Sampling including sampling plans + reduced testing where justified + (d) implement Batch Release by Qualified Person (QP) per applicable jurisdiction + (e) implement reference standards + reserve samples + retention + (f) implement OOS (Out of Specification) + OOT (Out of Trend) investigation + (g) maintain documentation of QC activities + decisions.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.