Module 3 2019

First Formal Validation Exercise

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Timing – prior to first in human testing

• Needs documenting (validation protocol?) (pre-approved?)

• Method Development has provided specificity & resolution

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Additional parameters for an HPLC method

• Solution (analyte) stability (48hr)

• Linearity – 6 solutions/levels (consider automating this through volume variation)

• System Precision – repeated injections

• For Impurities method - Limit of Quantification • check that your 0.05% standard is detectable • System Suitability

• Should reflect method purpose, development & validation data

May be performed using an automated approach - “Autovalidation” utilising robotic capabilities of instrumentation

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