Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -1
Question 1:
What is the objective of validation of an analytical procedure according to the ICH Q2?
Answer 1:
The objective of validation of an analytical procedure is to demonstrate its suitability for its intended purpose.
Question 2:
What is the scope of the ICH Q2 regarding geographical regions for which the validation is applicable?
Answer 2:
The document covers validation considerations for registration applications submitted within the European Community (EC), Japan, and the United States (USA). It does not necessarily cover testing requirements for registration in or export to other regions of the world.
Question 3:
Is the ICH Q2 intended to provide guidance on how to accomplish validation?
Answer 3:
No, the ICH Q2 explicitly states that it is not intended to provide direction on how to accomplish validation. Instead, it serves as a collection of terms and definitions for consideration during the validation process.
Question 4:
What are the four most common types of analytical procedures discussed in the ICH Q2?
Answer 4:
The four most common types of analytical procedures discussed in the document are:
Identification tests
Quantitative tests for impurities’ content
Limit tests for the control of impurities
Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product
Question 5:
What is the purpose of identification tests?
Answer 5:
Identification tests are intended to ensure the identity of an analyte in a sample. This is typically achieved by comparing a property of the sample to that of a reference standard.
Question 6:
How are impurity tests categorized in the ICH Q2?
Answer 6:
Impurity tests can be categorized as either quantitative tests or limit tests. Both types of tests aim to accurately reflect the purity characteristics of the sample, but they require different validation characteristics.
Question 7:
What is the purpose of assay procedures according to the ICH Q2?
Answer 7:
Assay procedures are intended to measure the analyte present in a given sample. In the context of the ICH Q2, assay represents a quantitative measurement of the major component(s) in the drug substance or drug product.
Question 8:
Are other analytical procedures, such as dissolution testing or particle size determination, addressed in the initial text on validation of analytical procedures?
Answer 8:
No, other analytical procedures like dissolution testing for drug products or particle size determination for drug substance are not addressed in the initial text on validation of analytical procedures. However, the document acknowledges their importance and states that validation of these additional analytical procedures may be addressed in subsequent documents.
Question 9:
What governs the validation characteristics that need to be evaluated for an analytical procedure?
Answer 9:
The objective of the analytical procedure governs the validation characteristics that need to be evaluated.
Question 10:
What are the typical validation characteristics that should be considered for an analytical procedure?
Answer 10:
The typical validation characteristics are:
Accuracy
Precision
Repeatability
Intermediate Precision
Specificity
Detection Limit
Quantitation Limit
Linearity
Range
Question 11:
How should robustness be addressed in the development of an analytical procedure?
Answer 11:
Robustness should be considered at an appropriate stage in the development of the analytical procedure, although it is not listed in the table of validation characteristics.
Question 12:
Under what circumstances may revalidation be necessary for an analytical procedure?
Answer 12:
Revalidation may be necessary in the following circumstances:
Changes in the synthesis of the drug substance
Changes in the composition of the finished product
Changes in the analytical procedure
