Definitions analytical procedures

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

GLl Validation definitions Validation of analytical procedures definition and terminology... 

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

ISO defines validation as Conformation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled. This is decided by using a number of performance characteristics. These are specificity, linearity, range, accuracy, precision, detection limit (DL), quantitation limit (QL), and robusmess. System suitability testing (SST) is an integral part of many analytical procedures. Definitions of these terms based on the recommendations of the ICH Guideline Q2 (Rl) are given in Table... 

International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures Definitions and Terminology. ICH-Q2A, Geneva (1995) (CPMP/ICH/ 381/95), Internet http //www.fda.gov/cder/guidance/ichq2a.pdf. 

Department of Health and Human Services, Food and Drug Administration.In-ternational Conference on Harmonisation Guideline on Validation of Analytical Procedures Definitions and Terminology Availability, docket no. 94D-0016. March 1,1995. 

Shah VP, Midha KK, Findlay JW et aL (2000) Bioanalytical Method Validation - A Revisit with a Decade of Progress. Pharmaceutical Research 17 1551-1557 CPMP/ICH/381/95 (1994) EEC Note for Guidance on Validation of Analytical Procedures Definitions and Terminology. London UK... 

Validation of Analytical Procedures Definition and Terminology, VICH GLl, International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), Brussels, 1998 (available at http / /WWW. vichsec. org/pdf/gl01 st7. pdf accessed... 

Analytical procedures sensitive to 2 ppm for styrene and 0.05 ppm or less for other items were used for examining the extracts. Even under these exaggerated exposure conditions no detectable levels of the monomers, of the polymer, or of other potential residuals were observed. The materials are truly non-food-additive by the FDA definitions. Hydrogen cyanide was included in the list of substances for analysis since it can be present at low levels in commercial acrylonitrile monomer, and it has been reported as a thermal decomposition product of acrylonitrile polymers. As shown here, it is not detectable in extracts by tests sensitive to... 

Most often studies will be accepted by regulatory authorities even if they do not contain all information. For example, a summary, the scope, a separate notice regarding the residue definition or a schematic diagram of the analytical procedure are helpful and may avoid additional questions, but they are not essential. Also, detailed specification of standard glassware or chemicals commonly used in residue analysis is less important. Finally, data about extraction efficiency or analyte stability can be offered in separate studies or statements, which are also valid for other methods. However, each method must precisely describe at the minimum ... 

In the ideal case only the diagonal elements of the sensitivity matrix are different from zero. Then no component disturbs any other and the analytical procedure works selectively (see Sect. 7.3). The K-malrix is defined analogously except that the elements are called kij, their definition is the same as the Sij according to Eq. (7.16). 

For each dmg substance, the maximum acceptable levels of the various impurities are described in the drug substance monograph or the specification included in the submissions to the regulatory authorities. In this chapter, the ICH Q6A [4] and Q6B [5] definition of specification is used. A specification consists of three parts the test (e.g. moisture content, impurities), references to the analytical procedure (e.g. high-performance liquid chromatography [HPLC], gas chromatography [GC]), and the acceptance criterion (e.g. not more than 0.50%). 

From the definitions given above it can be seen that there are two approaches to ruggedness testing (also equal to levels 1 and 2 given in the Acceptable Methods document [14]). In the first approach factors to be examined are selected from the set of operating and environmental conditions that are or could be stipulated in the analytical procedure. This kind of factors can be called procedure related factors. 

There are many reasons for the need to validate analytical procedures. Among them are regulatory requirements, good science, and quality control requirements. The Code of Federal Regulations (CFR) 311.165c explicitly states that the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Of course, as scientists, we would want to apply good science to demonstrate that the analytical method used had demonstrated accuracy, sensitivity, specificity, and reproducibility. Finally management of the quality control unit would definitely want to ensure that the analytical methods that the department uses to release its products are properly validated for its intended use so the product will be safe for human use. 

Each of these error components adds its own uncertainty to the total uncertainty budget of the analytical procedure. Therefore, the different error components are referred to as sources of uncertainty. Depending on the sources of uncertainty taken into account and thus on the conditions of the measurement, the overall MU will be different and another definition of MU will apply. This means that there is no single, straighforward definition of MU. It is rather a concept the interpretation of... 

ICH definition The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample that can be determined quantitatively with suitable precision and accuracy. The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample that can be detected but not necessarily quantitated as an exact value. 

ICH definition The linearity of an analytical procedure is its ability (within a given range) to obtain test results that are directly proportional to the concentration (amount) of analyte in the sample. 

Definition The accuracy of an analytical procedure expresses the closeness of agreement between the value that is accepted either as a conventional true value or as an accepted reference value and the value found. 

ICH definition The range of an analytical procedure is the interval between the upper and lower concentrations (amounts) of analytes in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy, and linearity (Figure 3.13). 

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