25.10.2004

Which Areas Are Evaluated During FDA Inspections of Laboratories?

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GMP News No. 486

GMPNews
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The new FDA Draft Guidance for Industry "Quality Systems Approach toPharmaceutical Current Good Manufacturing Practice Regulations" fromSeptember 2004 is intended to help manufacturers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:

training/qualification of personnel
adequacy of staffing for laboratory operations
adequacy of equipment and facility for intended use
calibration and maintenance programs for analytical instruments andequipment
validation and security of computerized or automated processes
reference standards; source, purity and assay, and tests toestablish equivalency to current official reference standards asappropriate
system suitability checks on chromatographic systems (e.g., GC orHPLC)
specifications, standards, and representative sampling plans
adherence to the written methods of analysis
validation/verification of analytical methods
control system for implementing changes in laboratory operations
required testing is performed on the correct samples
documented investigation into any unexpected discrepancy
complete analytical records from all tests and summaries of results
quality and retention of raw data (e.g., chromatograms and spectra)
correlation of result summaries to raw data; presence of unused data
adherence to an adequate Out of Specification (OOS) procedure whichincludes timely completion of the investigation
adequate reserve samples; documentation of reserve sampleexamination
stability testing program, including demonstration of stabilityindicating capability of the test methods

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Author:
Dr Günter Brendelberger