Ich Q2

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED TRIPARTITE GUIDELINE

VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1)

Current Step 4 version Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005)

ThisGuideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.

Q2(R1) Document History

First Codification

History

Date

NewCodification November 2005

Parent Guideline: Text on Validation of Analytical Procedures
Q2 Approval by the Steering Committee under Step 2 and release for public consultation. Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 26 October 1993 27 October 1994 Q2

Q2A

Q2

Guideline on Validation of Analytical Procedures:Methodology developed to complement the Parent Guideline
Q2B Approval by the Steering Committee under Step 2 and release for public consultation. Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 29 November 1995 6 November 1996 in Q2(R1)

Q2B

in Q2(R1)

Current Step 4 version
Q2A and Q2B The parent guideline is nowrenamed Q2(R1) as the guideline Q2B on methology has been incorporated to the parent guideline. The new title is “Validation of Analytical Procedures: Text and Methodology”. November 2005 Q2(R1)

VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY
ICH Harmonised Tripartite Guideline

TABLE OF CONTENTS
PART I: TEXT ON VALIDATION OF ANALYTICAL PROCEDURES..................................1 1. 2. Introduction ............................................................................................................1 Types of Analytical Procedures to be Validated ...................................................1

TABLE.............................................................................................................................3 GLOSSARY.......................................................................................................................4 PART II: VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY ..................6 INTRODUCTION.............................................................................................................6 1. 1.1. 1.2. 2. 3. 4. 4.1. 4.2. 4.3. 5. 5.1. 5.2. 5.3. 5.4. 6. 6.1. 6.2. 6.3 6.4SPECIFICITY .........................................................................................................6 Identification.......................................................................................................7 Assay and Impurity Test(s)................................................................................7LINEARITY.............................................................................................................8 RANGE.....................................................................................................................8 ACCURACY.............................................................................................................9 Assay...................................................................................................................9 Impurities (Quantitation) ................................................................................10 Recommended Data..........................................................................................10 PRECISION ..........................................................................................................10...