FDA Guidance for Industry: Data Integrity and Compliance with cGMP
Title:
FDA Guidance for Industry: Data Integrity and Compliance with cGMP
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf
Content:
The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.