validation

Question 1

what is method validation

Answer 1

is the process used to confirm if the analytical procedures performs the test that is suitable for its intended use.

Question 2

what do we need in the method

Answer 2

consistent (repeatability and productivity), reliable (precise) and accuracy (trueness).

Question 3

what is validation used for

Answer 3

is used to judge reliability, consistency and quality od the analytical result

Question 4

Why do we need statistics?

Answer 4

• when we did crappy experiment
• and if the measurement are crappy, statistics is needed

Question 5

what are the type of erroe

Answer 5

• systematic error: group/ bias
• gross error: outlier
• random error : noise

Question 6

how do you determine propagation error

Answer 6

• addition and substration
• multiplication and division

how to do so is in the studying paper
exercise do question in note page 8 and 9.

Question 6

how to quantify uncertainty

Answer 6

• top down: this is done by evaluating total method by using references, materials and calibration.
• bottom up: divides methods into smaller steps and determine uncertainty in each step and then combine total uncertainty.

Question 7

what is quality assurance

Answer 7

is systematic measure necessary to ensure that product will fulfill given demands on quality.

Question 8

When do we need to validate

Answer 8

• before initial of every routine work
• when transferred to another lab
• when condition are changed outside the scope of original method.

Question 9

what are the Parameters and tests for method validation

Answer 9

• specificity
• selectivity
• limit of detection
• limit of quantification
  -trueness
• reliability
  -quality
• consistency
  -stability
  -

Question 10

what is Limit of detection (LOD)

Answer 10

lowest amount of an analyte in the sample that can be detected

Question 11

Limit of Quantification (LOQ)

Answer 11

lowest amount of an analyte in the sample that can be quantitatively determined with suitable precision and accuracy

Question 12

what is the Ongoing Routine Tests that must be performed to ensure validation of method

Answer 12

• internal quality control: check if the measurement are repeatable.
• control chart historical: check how history activities
• control chart in laboratory: check the expected value and given value

Question 13

How to reduce the uncertainty of
determinations

Answer 13

• make signal sample as close to centroid as possible
• make the number for measurement of concentration and number of concentration in calibration curve as many as possible

Question 14

when to use Weighted Regression

Answer 14

• when heteroscedasticity is expected