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[Discussion on Partial Validation in Small Molecule Regulated Bioanalysis: Change in Analytical Instruments].
Keiko Nakai1, Hiroshi Kamimori, Akemi Nagao
1Bioanalysis Department, Advanced Technology Center, LSI Medience Corporation.
Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan
|November 3, 2015
Summary
Partial validation (PV) guidelines are needed for modified bioanalytical methods. This discussion group recommends specific validation items for changes in chromatographic instruments like pumps and mass spectrometers.
Area of Science:
- Bioanalysis
- Analytical Chemistry
- Pharmaceutical Science
Context:
- Regulatory agencies have released bioanalytical method validation guidelines.
- Existing guidelines lack details on partial validation (PV) for minor method changes.
- A discussion group (DG) was formed by the Japan Bioanalysis Forum (JBF) to address PV for chromatographic methods.
Purpose:
- To establish recommendations for partial validation (PV) of chromatographic bioanalytical methods following partial changes.
- To define the necessary validation items for specific analytical instrument modifications.
Summary:
- The DG discussed PV requirements for changes in analytical instruments: full system (same manufacturer/model), pump, autosampler, and mass spectrometer.
- Agreed PV items include calibration curve and reproducibility for full system changes.
- For pump, autosampler, and mass spectrometer changes, PV requires calibration curve, reproducibility, selectivity, and carryover, with mass spectrometer changes needing nearly full validation excluding recovery, dilution integrity, and stability.
Impact:
- Provides a framework for partial validation of bioanalytical methods, addressing a gap in current regulatory guidance.
- Facilitates efficient method revalidation by specifying essential validation parameters based on the nature of instrument changes.
- Aims to standardize PV practices in Japan, contributing to reliable bioanalytical data in pharmaceutical development.
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