ICH Guideline: Q2 Analytical Validation

Table of Contents

Q2 Analytical Validation:

The guideline Q2 analytical validation identifies validation parameters that are needed for various analytical methods.

Here are two revisions of the Q2 analytical validation guideline;

Q2(R1): Validation of Analytical Procedures: Text and Methodology:

The ICH Harmonised Guideline on Text (previously coded Q2A) was finalized under Step 4 in October 1994. This identifies the validation parameters needed for a variety of analytical methods. It also discusses the characteristics that must be considered during the validation of the analytical procedures which are included as part of registration applications.

The ICH Harmonised Guideline on Methodology (previously coded Q2B) was finalized under Step 4 in November 1996. It extends the Guideline Q2A to include the actual experimental data required, along with the statistical interpretation, for the validation of analytical procedures. The Guideline on Methodology has been incorporated into the Guideline on Text in November 2005 and then renamed Q2(R1), without any changes in the contents of the two Guidelines.

Date of Step 4: 1 November 2005

Status of Step 5: Implementation

Q2(R1) Analytical Validation

Q2(R2)/Q14: EWG Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation:

This topic was endorsed by the Assembly in June 2018.

The Q2(R2)/Q14 EWG will develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures, with a view to potentially combine both documents into one, for simplification and clarity.

Q2(R1) Revision

The scope of the revision of ICH Q2(R1) will include validation principles that cover the analytical use of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR or MS) some of which often require multivariate statistical analyses. The guideline will continue to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B. These proposed guidelines (Q2(R2) and Q14) are intended to complement ICH Q8 to Q12 Guidelines, as well as ongoing ICH Q13 for Continuous Manufacturing.

Q14 Analytical Procedure Development Guideline

The new guideline is proposed to harmonize the scientific approaches of Analytical Procedure Development and to provide the principles relating to the description of the Analytical Procedure Development process. This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

Q2(R2)/Q14: Analytical Validation Concept Paper

Q2(R2)/Q14: Analytical Validation Work Plan