Everyone involved in manufacture shares responsibility for quality. Each manufacturer should set up, write down and operate a quality system in which management and the relevant manufacturing staff take an active part, covering organisation, procedures, processes, resources and the activities that give confidence the API meets its quality and purity specifications, with every quality-related activity defined and documented. A quality unit independent of production should carry out both quality assurance and quality control, whether as separate units or one person or group depending on the size of the firm. The people allowed to sign off intermediates and APIs for release should be named. Quality activities should be recorded when they are done; departures from procedure documented and explained, and critical deviations investigated with the investigation and conclusion recorded. Materials should not be released or used until the quality unit has finished its evaluation, unless a suitable system (such as release under quarantine) permits it. Procedures should exist to tell responsible management promptly about regulator inspections, serious GMP failings, product defects and the actions that follow such as complaints, recalls and regulatory measures.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.