Section 17 covers any party, other than the original maker, that trades, takes possession of, repacks, relabels, manipulates, distributes or stores an API or intermediate, and all such parties should comply with the guide's GMP. They should keep full traceability of what they distribute, retaining and making available the original manufacturer's identity and address, purchase orders, bills of lading, receipt documents, the product name, the manufacturer's batch number, transport and distribution records, every genuine certificate of analysis (the original maker's among them), and the retest or expiry date. They should set up, document and operate an effective quality system as in section 2.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.