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International Pharmaceutical Regulatory Monitor
March 2012 | Vol. 40 No. 3
FDA, EMA, TGA Formalize Joint Inspection Program for APIs
The U.S. Food and Drug Administration (FDA) and its EU and Australian counterparts have developed a blueprint for operating joint good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) manufacturing facilities, the Australian Therapeutic Goods Administration (TGA) says.
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