Inspection by variables as an acceptance criterion in bioanalysis--a proposal

Area of Science:

• Bioanalytical method validation
• Quality control in pharmaceutical analysis

Background:

• Current bioanalytical acceptance criteria are often scientifically unjustified, lack immediate feedback, or ignore precision and accuracy.
• Existing methods like fixed range and 99% confidence intervals have significant limitations in real-time quality assessment.

Purpose of the Study:

• To propose and validate 'inspection by variables' as a robust acceptance criterion for bioanalysis.
• To address the deficiencies of current bioanalytical acceptance criteria by introducing a scientifically sound and efficient method.

Main Methods:

• Adapted the 'inspection by variables' procedure, originally from industrial quality control (ISO 3951, MIL-STD-414).
• Defined an acceptable quality level (AQL) of 6.50% with specifications at +/- 20% or +/- 15%.
• Applied the proposed method retrospectively to 14 authentic bioanalytical data sets.

Main Results:

• The proposed method, based on acceptable quality level (AQL), provides a scientifically justified approach to bioanalytical acceptance.
• Specifications of +/- 20% and +/- 15% correspond to coefficients of variation of approximately 15% and 12%, respectively.
• Retrospective application to 14 data sets demonstrated the utility and validity of the inspection by variables method.

Conclusions:

• Inspection by variables is a superior acceptance criterion for bioanalysis, offering improved scientific rigor and immediate quality assessment.
• The proposed AQL standard of 6.50% with defined specifications provides a reliable framework for bioanalytical quality control.
• This method enhances the efficiency and validity of bioanalytical data acceptance compared to traditional approaches.