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Guideline

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Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Laboratory Controls
Internet:http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124785.htm
Origin/Publisher:Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448
Content:As part of the cGMP initiative announced in August of 2002, and to help FDA be more transparent with cGMP policy, FDA developed this question and answer resource on Current Good Manufacturing Practices - Laboratory Controls