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October 06-08, 2026
Milan, Lombardy, Italy
Chemistry Validation
Validation is designed for intended use and executed using ICH Q2 (R1/R2) aligned characteristics to support release and stability testing.
Specificity
Confirm selective measurement of the analyte to eliminate risks and to support accurate quantification, demonstrating method suitability for its intended use.
Accuracy
Measure the trueness of the method to verify the absence of systematic error (bias) and to confirm the reliability of reported results.
Precision
Confirm reproducibility of results and assess random error to ensure method consistency in routine use and support data reliability and decision-making.
Linearity
Confirm proportional response to analyte concentration to define the working range of the method and detect non-linear behavior.
Range
Establish the usable limits of the method, ensuring that results reported within this interval are scientifically valid and reliable.
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Detection Limit (LOD)
Demonstrate the sensitivity of the analytical method, detecting very low levels of the analyte or impurity that may be critical for quality and safety.
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Quantitation Limit (LOQ)
Confirm that low-level results generated by the method are trustworthy and reproducible.
Robustness
Ensure method reliability under normal laboratory variations and that they do not significantly affect the results.
Microbiology Validation
Microbiological method validation demonstrates method suitability and reliable performance in the product matrix, in accordance with applicable pharmacopoeial and regulatory requirements.
Microbial Enumeration Methods
Demonstrate that the product matrix does not interfere with the accurate enumeration and recovery of viable bacteria, yeasts, and molds.
Specified Microorganisms
Demonstrate that the method can reliably detect specified microorganisms in the presence of the product matrix without inhibition or interference.
ANTIMICROBIAL EFFECTIVENESS
Demonstrate that the method accurately assesses preservative effectiveness by confirming recovery of challenge microorganisms in the product matrix.
Method Suitability & Recovery
Evaluate product interference and establish suitable conditions to ensure effective neutralization and recovery of microorganisms during microbiological testing.