Full system audit (ISO 9001 and GMP), including Gap Analysis and Report – 1-day on-site audit OR Remote Audit – Review of Quality System documents and records to evaluate, compliance with regulatory standards and internal procedures – Gap Analysis of the Company’s Quality System documents and ISO 9001 requirements. (Including but not limited to: Management responsibilities, customer requirements, manufacturing, equipment controls, monitoring & measurement, nonconformities, and corrective actions) – Gap Analysis of Company’s Quality System documents and 21 CFR part 111, Current Good Manufacturing Practice (cGMP) in manufacturing, packaging, labeling or holding operations for dietary supplements and 21 CFR part 117, Current Good Manufacturing Practice (cGMP), Hazard Analysis and risked-based preventative controls for human food – A list of recommendations/observations to obtain compliance |