Qualifying Analytical Instruments
The pharmaceutical industry employs a wide variety of analytical instrumentation to help ensure the efficacy and safety of their products. Unfortunately, the validity of the results produced can be influenced by factors other than the product itself.
The source of these potential errors are two-fold:
- Human (inappropriate method development or execution)
- Instrumental (errors in instrument and/or ancillaries)
If these sources of error can be eliminated then it is fair to assume that any anomalies in results are reliable and a direct result of the formulation itself.
Whilst GMP regulations require that companies should establish procedures to ensure the fitness for use of instruments that generate data supporting product testing, they do not provide definitive guidance as to how these goals are to be achieved.
USP has sought to address this problem by introducing a series of related Chapters as follows:
<1225> Validation of Compendial Procedures
<1226> Verification of Compendial Procedures
<1058> Analytical Instrument Qualification
The latter through the implementation of IQ/OQ/PQ procedures.
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