Quality Manual

The document describing the scope, processes, responsibilities, and interrelationships of the quality system.

Related sections

ICH Q10 §§1.5–1.8, 2–4 EU GMP Part I Chapter 1

Related terms

Pharmaceutical Quality System (PQS)2 casesQuality PolicyProcedure(s)2 cases

Real inspection findings

See 3 findings that mention this term

Source

ICH Q10, §1.8 Quality Manual; 식품의약품안전처, 「알기 쉬운 GMP 용어집」