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GMP News No. 486
25 October 2004
WhichAreas Are Evaluated During FDA Inspections of Laboratories?
The new FDA Draft Guidance for Industry "Quality Systems Approach toPharmaceutical Current Good Manufacturing Practice Regulations" fromSeptember 2004 is intended to help manufacturers to implement modernquality systems on the basis of the Agency's current good manufacturingpractice (CGMP) regulations (21 CFR Parts 210 and 211). The draft guidancealso refers to CPGM 7356.002 Compliance Program for Drug ManufacturingInspections, which can be found here.
In both guidelines, the Laboratory Control System is addressedas one of the key areas in pharmaceutical manufacturing. According to theCompliance Program Guidance Manual (CPGM) the Laboratory Control Systemincludes measures and activities related to laboratory procedures,testing, analytical methods development and validation or verification,and the stability program. When the Laboratory Control System is selectedfor coverage in System-Based FDA Inspections, all areas listed belowshould be covered during the inspection: