25 October 2004
Areas Are Evaluated During FDA Inspections of Laboratories?
The new FDA Draft Guidance for Industry "Quality Systems Approach to
Pharmaceutical Current Good Manufacturing Practice Regulations" from
September 2004 is intended to help manufacturers to implement modern
quality systems on the basis of the Agency's current good manufacturing
practice (CGMP) regulations (21 CFR Parts 210 and 211). The draft guidance
also refers to CPGM 7356.002 Compliance Program for Drug Manufacturing
Inspections, which can be found here.
In both guidelines, the Laboratory Control System is addressed
as one of the key areas in pharmaceutical manufacturing. According to the
Compliance Program Guidance Manual (CPGM) the Laboratory Control System
includes 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 selected
for coverage in System-Based FDA Inspections, all areas listed below
should 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 and
- validation and security of computerized or automated processes
- reference standards; source, purity and assay, and tests to
establish equivalency to current official reference standards as
- system suitability checks on chromatographic systems (e.g., GC or
- 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 which
includes timely completion of the investigation
- adequate reserve samples; documentation of reserve sample
- stability testing program, including demonstration of stability
indicating capability of the test methods
All these key compliance issues for
Laboratory Control Systems as mentioned in the CPGM Inspection Guide will
be addressed at the ECA Education Course "FDA-Compliance in
Analytical Laboratories", which takes place on 10 – 12 November
2004 in Madrid, Spain. Please click here
to see the complete programme. This Education Course shows how to
implement these cGMP Requirements in the everyday practice of
Pharmaceutical Quality Control Laboratories.
We would be happy to welcome you in Madrid.
Dr Günter Brendelberger
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