FDS: Method Validation Flashcards by Thomas Hasiweder

Q

WHAT’S THE INTENDED USE ?

general (4X)

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WHAT’S THE INTENDED USE ?

matrix, water

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Q

WHAT’S THE INTENDED USE ?

matrix, possibilities

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Q

WHAT’S THE INTENDED USE ?

targets

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Q

How many targets in which matrix ?

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How many targets ?

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Q

How many targets and techniques?

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Q

Looking at what level(s) ?

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Q

Looking at what level(s) ?

to what will it lead

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Q

Looking at what level(s) ?

Is the preset threshold a high concentration level or rather a trace concentration (at the limits of the technique)?

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Q

References, guidelines ……

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Q

Examples Need for a quantitative method (“validated”)

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Q

Example (hypothetical)

a drug product

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Q

Example (hypothetical)

informations

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Q

Example (hypothetical) Information from this objectives:

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Q

Example (hypothetical) Information from this objectives:

upper range

matrix

robustness

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Q

Method Validation VALIDATION OF AN ANALYTICAL METHOD : parameters

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Q

VALIDATION OF AN ANALYTICAL METHOD : parameters

type of analytical procedure

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Q

SPECIFICITY / SELECTIVITY

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Q

SPECIFICITY / SELECTIVITY

mass spectroscopie

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Q

SPECIFICITY / SELECTIVITY

non ms techniques

retention time

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Q

SPECIFICITY / SELECTIVITY

matrix interference

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Q

Specificity / selectivity

During optimization:

A

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Q

Specificity / selectivity

Technique specific (possible) criteria

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Q

Specificity / selectivity

hplc

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Q

Specificity / selectivity

monitored mass

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Q

Specificity / selectivity

isotope ratio

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Q

Specificity / selectivity

isotopes tungsten

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Q

Specificity / selectivity

LC/MSMS Method blank

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Q

Specificity / selectivity

LC/MSMS M.D.L. (spiked)

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Q

LINEARITY

graphs

A

Q

LINEARITY

examples

A

Q

Linear combination of parameters

A

Q

LINEARITY

Means of evaluating the linear relationship:

A

Q

LINEARITY

formulas

A

Q

LINEARITY

Arachidic acid

A

Q

ACCURACY AND PRECISION

general

A

Q

ACCURACY AND PRECISION

3 levels

A

Q

ACCURACY AND PRECISION (repeatibility)

A

Q

Accuracy

A

Q

Precision

A

Q

Method Validation

example

acceptance range

A

Q

Method Validation

RESULTS SUMMARY FOR IRGANOX 1010

A

Q

Confidence Limits

A

Q

Confidence Limits

Y?

A

Q

Measurement uncertainty

A

Q

Measurement uncertainty

example 2

A

Q

DETECTION LIMIT

A

Q

Method Detection Limit (M.D.L.)

A

Q

Method Detection Limit (M.D.L.)

Standard deviation

A

Q

QUANTIFICATION LIMIT

A

Q

DETECTION and QUANTIFICATION LIMIT (S/N)

A

Q

Detection Limit

LCMS

A

Q

RANGE OF THE METHOD

A

Q

ROBUSTNESS

analytical method

A

Q

ROBUSTNESS

typical variations

A

Q

SST – SYSTEM SUITABILITY TESTING

A

Q

VALIDATION OF AN ANALYTICAL METHOD : parameters

limit

A

Q

LIMIT TEST VALIDATION

A

Q

Methods to be used in different laboratories

A

Q

Method Validation: method transfer

A

Q

EURACHEM PRINCIPLES

A

Q

when should methods be validated

A

Q

EURACHEM PRINCIPLES

selection path

A

Q

EURACHEM PRINCIPLES

analytical requirements element

A

Q

types of bias

A

Q

Method Validation: IUPAC Guideline

definitions

A

Q

Method Validation: IUPAC Guideline

A

Q

Method Validation: IUPAC Guideline

changes

A

Q

Method Validation: IUPAC Guideline

judgement

A

Q

Acceptable RSD afo concentration

A

Q

Acceptable recovery afo concentration

A

Q

Statistical outliers

A

Q

Statistical outliers

table

A

Q

Statistical outliers

example

A