Method Validation of Analytical Procedures
Keywords:
Validation, Analytical Procedure, Accuracy, Precision, Robustness
Abstract
After the development of an analytical procedure, it is must important to assure that the procedure will consistently produce the intended a precise result with high degree of accuracy. The method should give a specific result that may not be affected by external matters. This creates a requirement to validate the analytical procedures. The validation procedures consists of some characteristics parameters that makes the method acceptable with addition of statistical tools.
References
1. Validation of Compendial Procedures <1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 734.
2. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 1.
3. Validation of Compendial Procedures <1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 735.
4. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 10.
5. Analytical Data-Interpretation and Treatment <1010>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 402.
6. Guideline on bioanalytical method validation, European Medicines Agency, London, UK, 2011; I: 8.
7. Validation of Analytical Procedures SC III F, British Pharmacopeia, British Pharmacopeia Commission, 2013
8. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 5.
9. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 7.
10. Validation of Compendial Procedures <1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 737.
11. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 8.
12. Validation of Compendial Procedures <1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 736.
13. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 11-12.
14. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 9.
15. Validation of Compendial Procedures <1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 738.
16. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 13.
17. Analytical Data-Interpretation and Treatment <1010>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 399.
2. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 1.
3. Validation of Compendial Procedures <1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 735.
4. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 10.
5. Analytical Data-Interpretation and Treatment <1010>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 402.
6. Guideline on bioanalytical method validation, European Medicines Agency, London, UK, 2011; I: 8.
7. Validation of Analytical Procedures SC III F, British Pharmacopeia, British Pharmacopeia Commission, 2013
8. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 5.
9. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 7.
10. Validation of Compendial Procedures <1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 737.
11. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 8.
12. Validation of Compendial Procedures <1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 736.
13. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 11-12.
14. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 9.
15. Validation of Compendial Procedures <1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 738.
16. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonised Tripartite guidelines, International Conference on Harmonisation of Technical Requirements For Registration Of Pharmaceuticals For Human Use, 2005; 13.
17. Analytical Data-Interpretation and Treatment <1010>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 399.
Published
2015-01-01
How to Cite
[1]
Gupta, P. 2015. Method Validation of Analytical Procedures. PharmaTutor. 3, 1 (Jan. 2015), 32-39.
Section
Articles
