International Conference Analytical Procedures

International Conference on Harmonization (Step 5, 1996), Q24A Validation of Analytical Procedures, Definitions and Terms. 

ICH Expert Working Group, Q2B Validation of Analytical Procedures Methodology, International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1996. 

International Conference on Harmonization, Guideline on validation of analytical procedures definition and terminology, Fed. Reg., 60(40), 11260 (1995). 

International Conference on Harmonization, Validation of analytical procedures methodology, step 2. The Third International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Yokohama, Japan. Nov. 29-Dec. 1, (1995). 

Source International Conference for Harmonization. Validation of Analytical Procedures ... 

International Conference on Harmonisation (ICH) Q2A, Text on validation of analytical procedures March 1995. 

ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures Text and Methodology Q2(R1), International Conference on Harmonisation, November 2005. 

Quantitative CE—MS studies were scarcely reported. " This subject is however of prime importance, particularly for the pharmaceutical industry where the reliability of analytical data is essential. For this reason, method development is generally followed by an evaluation of quantitative performance using an appropriate validation procedure performed in agreement with criteria established by the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) and the Food and Drug Administraction (FDA) guidelines, or Societe Franqaise des Sciences et Techniques Pharmaceutiques (SFSTP) commissions. ... 

International Conference of Harmonization Q2B, Validation of Analytical Procedures Methodology, Geneva, Switzerland, 1996. 

International Conference on Harmonization (ICH) (2005, Nov.), Harmonised tripartite guideline Q2(R1), Validation of analytical procedures Text and methodology. 

Moffat, A.C., Trafford, A.D., Jee, R.D. and Graham, P. (2000) Meeting of the international conference on harmonisation s guidelines on validation of analytical procedures Quantification as exemplified by a near-infrared reflectance assay of paracetamol in intact tablets Analyst 125, 1341-1351. 

International Conference on Harmonisation, Guideline on Validation of Analytical Procedures, Q2A, Code of Federal Register, Vol 60, no. 40, p. 11260, March (1995). 

Department of Health and Human Services, Food and Drug Administration. International Conference on Harmonisation Guideline on Validation of Analytical Procedures Methodology Availability, docket no. 96D-0030. May 19,1997. 

International Conference on Harmonisation, Guidance for industry Validation of analytical procedures Methodology, ICH-Q2B, Nov. 1996. 

International Conference on Harmonisation Draft Guideline on Vali- dation of Analytical Procedures for Pharmaceuticals Availability, Fed. Reg., 59 9750 (1994). 

International Conference on Harmonization (1997). Guideline on Validation of Analytical Procedures Methodology. Federal Register 62, 27463-27467. 

The robustness of an analytical method can be described as the ability to reproduce the method in different laboratories or under different circumstances without the occurrence of unexpected differences in the obtained results. The term ruggedness is considered here as a synonym for robustness. The robustness of a method is tested in a robustness test. The most frequently u.sed definition for robustness in this area is due to the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) [79,80. It defines robustness as follows. The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage."... 

G. Mazerollcs, D. Mathicu. R. Phan-Tan-Luu and A.M. Sioufli. J. Chromatogr. 485 (1989) 433, Guidelines prepared within the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human L se (ICH), Validation of Analytical Procedures, 199.3. p. I. 

To the pharmaceutical world, the meaning of analytical methods validation is the process to confirm that a method does what it purports to do, that is, to document through laboratory studies that the measurement procedure can reliably assess the identity, strength, and/or quality of a bulk drug substance, excipient, or finished pharmaceutical product. To provide consistent, worldwide regulatory expectations, previously unavailable, the International Conference on Harmonization has defined the methods validation... 

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