INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
ICH H ARMONISED T RIPARTITE G UIDELINE
V ALIDATION OF A NALYTICAL P ROCEDURES:
T EXT AND M ETHODOLOGY
Q2(R1)
Current Step 4 version
Parent Guideline dated 27 October 1994
(Complementary Guideline on Methodology dated 6 November 1996
incorporated in November 2005)
This Guideline 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 New Codification November
意识形态汇报2005羽毛球林丹
Parent Guideline: Text on Validation of Analytical Procedures Q2 Approval by the Steering Committee under Step 2 and relea for public consultation. 26 October 1993 Q2
Q2A Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 27 October 1994 Q2
Guideline on Validation of Analytical Procedures: Methodology
developed to complement the Parent Guideline Q2B Approval by the Steering Committee under Step 2 and relea for public consultation. 29 November 1995
in Q2(R1) Q2B Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 6 November 1996 in Q2(R1)
Current Step 4 version中国百科全书
Q2A and Q2B The parent guideline is now renamed 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:
T EXT AND M ETHODOLOGY
ICH Harmonid Tripartite Guideline
TABLE OF CONTENTS
PART I:
TEXT ON VALIDATION OF ANALYTICAL PROCEDURES (1)
1.Introduction (1)
2.Types of Analytical Procedures to be Validated (1)
TABLE (3)
GLOSSARY (4)
PART II:
VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY (6)
INTRODUCTION (6)
1.SPECIFICITY (6)
1.1.Identification (7)
1.2.Assay and Impurity Test(s) (7)
2.LINEARITY (8)
3.RANGE (8)
4.ACCURACY (9)
4.1.Assay (9)
4.2.Impurities (Quantitation) (10)
4.3.Recommended Data (10)
顺丰统一结算系统5.PRECISION (10)
5.1.Repeatability (10)
5.2.Intermediate Precision (10)
市场督导5.3.Reproducibility (10)
5.4.Recommended Data (10)
6.DETECTION LIMIT (11)
6.1.Bad on Visual Evaluation (11)
6.2.Bad on Signal-to-Noi (11)
诚信考试黑板报
6.3Bad on the Standard Deviation of the Respon and the Slope (11)
6.4Recommended Data (11)
Validation of Analytical Procedures: Text and Methodology
7.QUANTITATION LIMIT (12)
7.1.Bad on Visual Evaluation (12)
7.2.Bad on Signal-to-Noi Approach (12)
7.3.Bad on the Standard Deviation of the Respon and the Slope (12)
7.4Recommended Data (13)
8.ROBUSTNESS (13)
9.SYSTEM SUITABILITY TESTING (13)
PART I:
T EXT ON V ALIDATION OF A NALYTICAL P ROCEDURES
ICH Harmonid Tripartite Guideline
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on
鸡块面的家常做法27 October 1994, this guideline is recommended for adoption
to the three regulatory parties to ICH
1. Introduction
This document prents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. This document does not necessarily ek to cover the testing that may be required for registration in, or export to, other areas of the world. Furthermore, this text prentation rves as
a collection of terms, and their definitions, and is not intended to provide
direction on how to accomplish validation. The terms and definitions are meant to bridge the differences that often exist between various compendia and regulators of the EC, Japan and USA.
The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpo. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included. Other analytical procedures may be considered in future additions to this document.
2. Types of Analytical Procedures to be Validated
The discussion of the validation of analytical procedures is directed to the four most common types of analytical procedures:
- 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 lected component(s) in the drug product.
Although there are many other analytical procedures, such as dissolution testing for drug products or particle size determination for drug substance, the have not been addresd in the initial text on validation of analytical procedures.
Validation of the additional analytical procedures is equally important to tho listed herein and may be addresd in subquent documents.
A brief description of the types of tests considered in this document is provided
below.
银耳炖雪梨- Identification tests are intended to ensure the identity of an analyte in a sample. This is normally achieved by comparison of a property of the sample
(e.g., spectrum, chromatographic behavior, chemical reactivity, etc) to that of
a reference standard;
