[quote=Shahid Ali]Dear Ruth
All u described is about inhouse method. but here we are discussing about Phamacopeal method. What is your openion abou that???[/quote]
Compendial and other standard methods should be verified to ensure suitability for their intended use. For example FDA’s 21 CFR Part 211 states: The suitability of all testing methods used shall be verified under actual conditions of use.
There are two guideline documents important to any method validation process : USP Chapter 1225: Validation of Compendial Methods; and the International Conference on Harmonization (ICH) Guideline: Validation of Analytical Procedures: Text and Methodology Q2 (R1). While the USP is the sole legal document in the eyes of the FDA, this article draws from both guidelines as appropriate for definitions and methodology.
Ruggedness is defined in the current USP guideline as the degree of reproducibility of test results obtained by the analysis of the same samples under a variety of conditions, such as different
* reagent lots;
* elapsed assay times;
* assay temperatures; and
That is, it is a measure of the reproducibility of test results under the variation in conditions normally expected from laboratory to laboratory and from analyst to analyst. The use of the term ruggedness, however, is not used by the ICH, but is certainly addressed in guideline Q2 (R1) under intermediate precision (within-laboratory variations; different days, analysts, equipment, and so forth) and reproducibility (between-laboratory variations from collaborative studies applied to the standardization of the method). It is also falling out of favor with the USP, as evident in recently proposed revisions to chapter 1225, where references to ruggedness have been deleted to harmonize more closely with ICH, using the term “intermediate precision”