VALIDATION OF ANALYTICAL PROCEDURES: A COMPARISON OF ICH Vs PHARMACOPOEIA Vs FDA

8. COMPARISON
8.1 According to USP
The performance characteristics required can be referred to as “Eight steps of  Method Validation”.  These analytical performance characteristics are
1.    Accuracy
2.    Precision
3.    Specificity
4.    Detection limit
5.    Quantiation limit
6.    Linearity and range
7.    Ruggedness
8.    Robustness

8.2 According to ICH
1.    Accuracy
2.    Precision
3.    Repeatability
4.    Intermediate precision
5.    Specificity
6.    Detection limit
7.    Quantiation limit
8.    Linearity
9.    Range
10.   Robustness
11.   System suitability

8.3 According to FDA Reviewer Guidance
1.    Accuracy
2.    Precision
3.    Repeatability
4.    Injection repeatability
5.    Analysis repeatibility
6.    Intermediate precision
7.    Specificity / selectivity
8.    Reproducibility
9.    Detection and quantiation limit
10.    Quantiation limit
11.    Linearity
12.    Range
13.    Robustness
14.    System suitability specifications and tests
15.    Sample solution stability ²

8.4 According to European guidelines
1.    Accuracy
2.    Precision
3.    Repeatability
4.    Intermediate precision
5.    Specificity
6.    Detection limit
7.    Quantiation limit
8.    Linearity
9.    Range ³

Table III -  USP data elements required for Validation¹³

* indicates may be required on nature of specific test

Table IV - ICH elements required for Validation ²

 Table V Japanese Pharmacopoeia elements required for Validation¹⁴

* either intermediate precision or reproducibility should be evaluated depending upon circumstances in which analytical tests are performed

Table VI - Comparison of Analytical Parameters required for Validation ²

Conclusion
This article summarizes the validation parameters that are required according to the requirements of ICH Q2R(1). The paradigm shift under cGMP in the twenty - first century that requires the bench - level scientist to have the scientific and technical Understanding, product knowledge, process knowledge, and/or risk assessment abilities to appropriately execute the quality functions of analytical method validation In this article the method validation process and the minimum requirements to be included in a regulatory method are also discussed. Also a comparison between various parameters have been made i.e. in ICH, Pharmacopoeia & FDA and a table has been drawn from those observations

REFERENCES
1.    Analytical Method Validation: Principles and Practices Available from URL http://www.pharmaquality.com/Media/.../Pgs28-31_ChapterPDF.pdf (Accessed on 06-August-2011)
2.    Carstensen T. Jens, Rhodes C.T. “Drug Stability Principles and Practices” Third edition revised and expanded 2004, Marcel Dekker inc. P.NO.- 353-360
3.    European network of official medicines control laboratories “Validation of Analytical Procedures”, june 2005 Available from URL http:// www.european-accreditation.org/.../00400OMCL%2005%2047%20 DEF3  (Accessed on 08-August-2011)
4.    Guidance for Industry Q2B Validation of Analytical Procedures : Methodology, Nov.1996 Available from URL http:// www.fda.gov/downloads/. ../Guidances/ UCM 128049.pdf (Accessed on 25-July-2011)
5.    Haider Imtiaz Syed “ Validating Standard Operating Procedure” second edition 2008 published by Informa Healthcare P.No.-448-460
6.    Huber Ludwig “Validation of Analytical methods and processes” “ Pharmaceutical process Validation” 3rd edition revised & expanded 2003 Vol. 129 .Marcel dekker inc.
7.    Huber Ludwig “Validation of Analytical Methods” A Primer, 2007   Published by Agilent Technologies Available from URL http:// www.chem.agilent .com/Library /primers/Public/5990-5140EN.pdf P.NO- 4(Accessed on 09-August-2011)
8.    International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human use.”Validation of Analytical Procedures: Text and Methodology.ICH Q2(R1). Geneva(Nov. 2005) (Accessed on 25-July-2011)
9.    Nash A. Robert “Validation of Analytical Procedure” “Encyclopedia of Pharmaceutical Technology” 3rd edition, 2003 volume 1, edited by James Swarbrick Informa healthcare Inc. P.NO – 3928-3929
10.    Sarrio V. Robert, Silvestri J. Loui “ Validation of Analytical Assays and test methods for the pharmaceutical Laboratory”,1996 Available from URL http://www.regulatory.com/forum/article/test-val.html(Accessed on 26-July-2011)
11.    Sharma P.P “Validation in Pharmaceutical Industry- Concept, Approaches & Guidelines, First Edition 2007 Published by Vandana Publications Pvt. Ltd. P.NO 361-362
12.    Sharma P.P. “How to Practice GLP”, Second edition 2008 Published by Vandana Publications Pvt. Ltd. P.NO.-361-362
13.    U.S. Pharmacopoeia (USP) 2007 General Chapter <1225> “Validation of Compendial Procedures”, USP, Rockville, MD P.NO..-2748-2749
14.    Validation of Analytical Procedures 1330/ General Information JP XIV Available from URL http:// lib.njutcm.edu.cn/yaodian /jp/14data/ Validation_ of_Analytical  _Pr.pdf (Accessed on 10-August-2011)
15.    Validation of Analytical Procedures: Definition and Terminology, October 1998 (at step 7 for implementation) VICH (International cooperation on harmonisation of technical requirements for registration of veterinary medicinal plants) P.NO – 3 Available from URL http:// www.fda.gov/ downloads/ Animal Veterinary/ .. ./UCM052377.pdf (Accessed on 09-August-2011)
16.    WHO Expert committee on specifications for pharmaceutical preparations, thirty    second report world health organization geneva 1992  Available from URL http:// www.who.int/prequal/info_general/.../ WHO_TRS_929 _a nnex5FDCs.pdf P.NO. 4 (Accessed on 06-August-2011)

NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.

SUBMIT YOUR ARTICLE/PROJECT AT articles@pharmatutor.org

Subscribe to Pharmatutor Alerts by Email

FIND OUT MORE ARTICLES AT OUR DATABASE