ICH q2

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

ICH Q2(R2) Guideline

1 INTRODUCTION

1.1 Objective

This guideline presents elements for consideration during the validation of analytical

procedures included as part of registration applications. Analytical procedure validation forms

a part of the analytical procedure lifecycle, as described within ICH Q14 Analytical Procedure

Development. ICH Q2(R2) provides guidance on selection and evaluation of the various

validation tests for analytical procedures. This guideline includes a collection of terms and their

definitions, which are meant to bridge the differences that often exist between various

compendia and documents of the ICH member regulatory authorities.

The objective of validation of an analytical procedure is to demonstrate that the analytical

procedure is fit for the intended purpose. Further general guidance is provided on validation

studies for analytical procedures.

1.2 Scope

This guideline applies to analytical procedures used for release and stability testing of

commercial drug substances and products, hereafter referred to as ‘products’. The guideline

can also be applied to other analytical procedures used as part of the control strategy (ICH Q10

Pharmaceutical Quality System) following a risk-based approach. The scientific principles

described in this guideline can be applied in a phase-appropriate manner to analytical

procedures used during clinical development.

The guideline is directed to common uses of analytical procedures, such as assay, potency,

purity, impurity (quantitative or limit test), identity or other quantitative or qualitative

measurements.

2 GENERAL CONSIDERATIONS FOR ANALYTICAL PROCEDURE

VALIDATION

This guideline indicates the data which should be presented in a regulatory submission.

Analytical procedure validation data should be submitted in the corresponding sections of the

application (ICH M4Q The Common Technical Document For The Registration Of

Pharmaceuticals For Human Use). Relevant data collected during validation (and any

methodology used for calculating validation results) should be submitted to demonstrate the

suitability of the procedure for the intended purpose. Suitable data derived from development

studies (see ICH Q14) can be used as part of validation data. When an established platform

analytical procedure is used for a new purpose, validation testing can be abbreviated, if

scientifically justified.

Approaches other than those set forth in this guideline may be applicable and acceptable with

appropriate science-based justification. The applicant is responsible for designing the

validation studies and protocol most suitable for their product.

Reference materials, or othersuitably characterised materials, with documented identity, purity,

or any other characteristics as necessary, should be used in the validation study.

In practice, the experimental work can be designed so that the appropriate performance

characteristics are considered simultaneously to provide sound, overall knowledge of the

performance of the analytical procedure, for instance: specificity/selectivity, accuracy, and

precision over the reportable range.

About more details get from ICH: https://database.ich.org/sites/default/files/ICH_Q2%28R2%29_Guideline_2023_1130.pdf

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