nx_cgmp.nx

nx_cgmp.nx -- GTM SUITE / 21 CFR 111 cGMP READINESS rung. Deepens the plan engine's coarse "manufacturing / identity" attestations into the real sub-part checklist a dietary-supplement contract manufacturer is audited against -- so the plan can say not "qualify a cGMP facility" but exactly which requirements are missing, worst-first. THE ORDERING IS BY WHAT DRAWS A WARNING LETTER. FDA 483 observations and warning letters cluster on a knowable few requirements: no established specifications, no 100% identity testing of incoming components, no master manufacturing record, no batch record, no quality-control unit. Those are tagged CRITICAL and a facility is not audit-ready while any is open -- cgmp_first_critical_gap returns the worst one first, the same kill-order discipline as the production-readiness engine it feeds. EVERY REQUIREMENT IS AN OPERATOR ATTESTATION, HONESTLY. This organ cannot inspect a plant; it tracks which requirements are DECLARED met and scores the gap, weighting CRITICAL > MAJOR > MINOR. It replaces a single yes/no "gmp_qualified" flag with an actionable breakdown, not with a pretense of having audited anything. THE CITATIONS ARE REAL so a plan line points at the actual regulation. Grounding (cited; researcher-groundable): fda_21cfr111_current_good_manufacturing_practice_dietary_supplements 111_70_specifications · 111_75_component_identity_testing 111_205_master_manufacturing_record · 111_255_batch_production_record 111_65_quality_control_operations · fda_483_warning_letter_cgmp_patterns genealogy_id: supplement_gtm + service_infrastructure