FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
Title:
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
Origin/Publisher:
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf
Content:
This guidance describes a comprehensive quality systems model, which, if implemented, will allow manufacturers to support and sustain robust, modern quality systems that are consistent with CGMP regulations