Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -3
Question 1:
What is the purpose of the ICH Q2 discussed?
Answer 1:
The purpose of the ICH q2 is to provide guidance and recommendations on how to consider various validation characteristics for each analytical procedure, complementing the parent document which discusses the characteristics to be considered during the validation of analytical procedures.
Question 2:
When might the overall capabilities of multiple analytical procedures be investigated together?
Answer 2:
The overall capabilities of multiple analytical procedures may be investigated together, for example, when demonstrating specificity, to ensure the quality of the drug substance or drug product.
Question 3:
What kind of data should be presented in a registration application according to the document?
Answer 3:
All relevant data collected during validation, along with the formulae used for calculating validation characteristics, should be submitted and discussed as appropriate in a registration application.
Question 4:
What is the responsibility of the applicant regarding the validation procedure?
Answer 4:
It is the responsibility of the applicant to choose the validation procedure and protocol most suitable for their product, while ensuring that the main objective of validation, demonstrating suitability for the intended purpose, is met.
Question 5:
What is emphasized regarding analytical procedures for biological and biotechnological products?
Answer 5:
Due to their complex nature, analytical procedures for biological and biotechnological products may be approached differently than described in the ICH Q2, requiring tailored validation approaches.
Question 6:
Why is an investigation of specificity necessary during the validation of analytical procedures?
Answer 6:
An investigation of specificity is necessary during the validation of analytical procedures to ensure that the procedure can differentiate between the analyte and closely related compounds, impurities, or interfering substances.
Question 7:
What does the ability of identification tests to discriminate between compounds entail?
Answer 7:
The ability of identification tests to discriminate between compounds entails being able to differentiate compounds with closely related structures that are likely to be present. This discrimination is confirmed by obtaining positive results from samples containing the analyte and negative results from samples without the analyte.
Question 8:
When might it be challenging to demonstrate complete discrimination in an analytical procedure?
Answer 8:
It might be challenging to demonstrate complete discrimination in an analytical procedure when it is not always possible to ensure specificity for a particular analyte. In such cases, a combination of two or more analytical procedures is recommended to achieve the necessary level of discrimination.
Question 9:
What additional confirmation can be performed in identification tests to ensure specificity?
Answer 9:
In addition to obtaining positive results from samples containing the analyte and negative results from samples without the analyte, identification tests may also be applied to materials structurally similar to or closely related to the analyte to confirm that a positive response is not obtained.
Question 10:
How should the choice of potentially interfering materials be made during specificity testing?
Answer 10:
The choice of potentially interfering materials should be based on sound scientific judgment, considering the interferences that could occur. Materials structurally similar to or closely related to the analyte should be selected for testing.
