Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistAll AssessmentsReadiness Assessment, 8 Questions, About 7 Minutes
CGMP Quality System
For drug and biologic firms: rate your CGMP quality system against the 21 CFR 211 areas that draw the most enforcement.
21 CFR 211.22
Is the quality unit independent and effective?
What FDA inspects: 21 CFR 211.22, responsibilities of quality control unit. See the trend