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Method validation validated methods, availability

Method qualification is based on ICH method validation guidelines. Method type (purity or identity) will dictate the level of qualification testing necessary. Several strategies for method qualification and validation exist and are based on needs, resources available, and the project timeframe. One approach is to perform minimal development and qualification, which may be necessary for projects with shorter timelines, but it may place more burden and risk on future validation activities for robustness testing, and can result in failure. As discussed in Chapter 4, an alternate approach would invest more time and resources into method development, followed by extensive qualification and robusmess testing to determine if further development is... [Pg.358]

This chapter describes the validated alternative methods available for the developmental toxicity evaluation of new cosmetic ingredients, with particular attention to the detection of teratogenicity. [Pg.91]

FDA Guidance for Industry, Bioanalytical Method Validation, May 2001 (available from www.fda.gov). [Pg.137]

Although there are only a limited number of methods that have been validated specifically for soft drinks, there are around 80 validated methods available for the analysis of fruit juices, most of which would work equally well for soft drinks. These methods are published in the International Fruit Juice Union (IFU) handbook of analytical procedures, which offers the best reference collection of methods for the analysis of fruit juices in the world, with new methods added on a regular basis (Anon, 2004a). The IFU s collection of analytical methods covers most of the main procedures required to assess the quality and authenticity of fruit juices and nectars. The methods are hsted on the IFU s website (http //www.ifu-fruitjuice.com) at the time of writing they cannot be purchased directly from there, but they can be obtained from the Swiss Fruit Union, Zug, and details of how to do this are given on the website. It is possible that at some time the methods will be made available directly from the website. [Pg.237]

Briefly, there are many nationally (ASTM, Environmental Canada, and USEPA) and internationally validated methods available for assessing developmental and reproductive effects in aquatic plants and animals (ASTM, Environment Canada, ISO, and OECD). For plants, examples include the microalgal, freshwater macrophytes and marine algal growth tests (Nyholm and Kallquist 1989 Wang 1990 Eklund 2005). [Pg.85]

At the present time, there is no optimized, validated method available for the comparison of mescaline-containing samples. In addition to phytochemical (drug) analyses, another opportunity may exist through the use of DNA analyses (cf. Section 4.4.3.4 above in the case of cannabis profiling). At present, such methods have not been reported in the scientific literature, in the public domain, and thus comparison of peyote samples remains problematic. [Pg.124]

A classic example of this commonly adopted approach is the determination of a metallic trace element in a defined solid environmental matrix. This determination may involve an optimised digestion stage pertinent to a particular element and a specific matrix. Because this method may be the only validated method available, the digestion procedure is then used to determine other suites of metals in other matrices. Whether the actual procedures used are appropriate to these other metals in the suite or indeed the matrix is often not fully appreciated, or even considered, and results are generated in the hope that they will be satisfactory for the purpose. Without some form of verification, this assumption may be totally erroneous and the results generated may not be fit for purpose. [Pg.24]

At present, there is no completely valid method available to directly calculate the interlaboratory precision from the intralaboratory precision or vice versa. This is unfortunate because frequently only one type of precision estimate is available for a method. ITowever, in general, the following comments are applicable. First, the intralaboratory precision should be smaller than the interlaboratory precision because of additional variables in the latter. Second, if the interlaboratory precision is much larger than the intralaboratory precision, this indicates that the method is very technique-sensitive. Such information can be very important when considering a project that might involve several laboratories analyzing the same sample. [Pg.4105]

Flammability shall be determined by tests or by calculation in accordance with ISO 10156 (incorporated by reference See 1910.6). Where insufficient data are available to use this method, equivalent validated methods may be used. [Pg.167]

In considering the corrosion of magnesium and its alloys it is important to examine the methods available for assessing corrosion tendencies and particularly those known as accelerated tests. Tests carried out by immersion in salt water or by spraying specimens regularly with sea-water are worthless as a means of determining the resistance of magnesium alloys under any other than the particular test conditions. Extrapolation to less corrosive conditions is not valid and even the assessment of the value of protective measures by such means is hardly possible. The reason is to be found in the fact that corrosion behaviour is directly related to the formation of insoluble... [Pg.749]

Second, the newly developed and collaboratively evaluated method may need to be compared to another validated procedure if available, which requires an additional and different data set. [Pg.288]

Other considerations could include availability of reagent(s) or equipment, method for routine analyses vs limited samples, and confirmatory method vs multi-residues. Plan for method validation and/or analytical quality control. [Pg.51]

Many experts in Europe have tested the methods of both standards with various pesticide-matrix combinations in their own laboratories. Consequently, the responsible working groups of CEN TC 275 concluded that these are the best methods available. Nevertheless, there is no complete validation of all possible pesticide-matrix combinations. However, for most multi-residue methods within the standards all those pesticides which had been successfully tested in method validation trials and/or proficiency tests are listed. Also, matrices which had been examined in ring tests are listed. [Pg.113]

Even if most examples and procedures presented apply to in-house validation, the procedure does not distinguish between validations conducted in a single laboratory and those carried out within inter-laboratory method performance studies. A preference for inter-laboratory studies can be concluded from the statement that laboratories should always give priority to methods which have been tested in method performance studies. Within the procedure a profound overview of different categories of analytical methods according to the available documentation and previous external validation is given. For example, if a method is externally validated in a method performance study, it should be tested for trueness and precision only. On the other hand, a full validation is recommended for those methods which are published in the scientific literature without complete presentation of essential performance characteristics (Table 9). [Pg.121]

AOAC/FAO/IAEA/IUPAC Expert Consultation, Guidelines for Single Laboratory Validation of Analytical Methods for Trace-level Concentrations of Organic Chemicals, Workshop, 8-11 November 1999, Miskolc, Hungary (1999). Also available on the Word Wide Web http //www.iaea.oi trc/(see pesticides —> method validation). [Pg.133]

SFE instrument development has greatly been stimulated by the desire of the Environmental Protection Agency (EPA) to replace many of their traditional liquid-solvent extraction methods by SFE with carbon dioxide. In the regulatory environment, EPA and FDA approved SFE and SFC applications are now becoming available. Yet, further development requires interlaboratory validation of methods. Several reviews describe analytical SFE applied to polymer additives [89,92,324]. [Pg.90]

In most situations analysts can achieve a rapid reasonable separation of compounds using an appropriate standard CE method with generic operating conditions [877]. This eliminates or reduces dramatically the need for method development. Major instrumental error sources in CE are detection, integration and injection. General guidelines for validation of CE methods are available and similar to those of HPLC [878]. Validated CE methods often perform the same as, or better than, the corresponding HPLC methods. [Pg.276]

There are a number of things to consider, but the most important is understanding the needs of the customer. Is the total sugar content of the product required or the lactose content The level of uncertainty in the result that is acceptable also helps focus on the choice of method. Once the method is chosen and validated, it is then important to ensure that all of the equipment is available and in a proper state of calibration. Then, all that remains is to have sufficient trained staff to carry out the analysis. Once the experimental results have been obtained and the data treatment is complete, the report can be written. The report also has to meet the customer requirements and should be written in an unambiguous way which is clear to the non-specialist. [Pg.5]

If the validated test method requires 1 g of material but only 100 mg is available, you must find out if the method is sufficiently robust to stand this amount of scaling down. This has to be checked before the analysis starts, i.e. the method must be validated for analysis of 100 mg of material. Even if the method of analysis is found to be robust, scaling down is only a viable option if the smaller test portion size remains representative, within acceptable limits. This will depend on the homogeneity of the material. [Pg.35]

When no validation data are available, then all of the relevant parameters will have to be studied. The degree of rigour with which the study is carried out will depend on issues such as criticality of the measurement and the availability of validation data on similar methods. There will be cases in the laboratory where a method has been used, satisfactorily, for a long period of time but there is no documentation to demonstrate the performance of the method. It seems unreasonable to require full revalidation when a method has been used successfully for some years. However, the need for objective evidence prevents the validity of such a method being taken for granted. A possible approach is to follow the plan below ... [Pg.76]

You may have noticed that sampling does not appear in Table 4.6. Although sampling is an important issue in chemical analysis, it is not part of method validation. It is assumed that there is sufficient sample available and that the method is validated using materials that have the same or very similar physical and chemical form. Sampling is discussed in detail in Chapter 3. [Pg.78]

In order to ensure that results yielded by a method are as accurate as possible, it is essential to validate the method by analysing standards which have an accepted analyte content, and a matrix similar to that of the sample. The accepted values for these validated standards are obtained by extensive analysis, using a range of different methods. Internationally accepted standards are available. [Pg.624]


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See also in sourсe #XX -- [ Pg.455 , Pg.736 ]




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Availability of (pre)validated methods in Europe

Partially validated methods, availability

Validated methods

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