Methods/test procedures transfer

Sinkers can significantly influence the dissolution profile of a drug. Therefore, the use of sinkers should be part of the dissolution method validation. If equivalent sinkers are identified during the sinker evaluation and validation, the equivalent sinkers should be listed in the written dissolution test procedure. When a dissolution method utilizes a dissolution sinker and is transferred to another laboratory, the receiving laboratory should duplicate the validated sinker design(s) as closely as possible. 

Procedure Transfer about 300 mg of the test article (accurately weighed) to a 150-mL beaker, dissolve in 1.5 mL of anhydrous formic acid, and add 60 mL of glacial acetic acid. Add crystal violet Test Solution, and immediately titrate with 0.1 N HCIO4 to a green endpoint. Perform a blank determination, and make any necessary correction. Each milliliter of 0.1 N HCIO4 is equivalent to 29.43 mg of aspartame. The method description cautions that a blank titration exceeding 0.1 mL may be due to excessive water content, and may cause loss of visual endpoint sensitivity. 

Validation of analytical methods and procedures is one of the important duties of development laboratories in the R and D division of major pharmaceutical companies. Validation of the testing method in a QC laboratory is implemented mainly at the time of transfer or introduction of the method from the development laboratory of the group companies or from outside. However, it often becomes necessary to develop a new or improved method of analysis for the QC laboratories own use. 

Top-Feed Test Procedure The sequence of operations with a top-feed leaf test is the same as in a bottom-feed test, except that the leaf is not immersed in the slurry. The best method for transferring the slurry to the top-feed leaf is, of course, a function of the characteristics of the slurry. If the particles in the slurry do not settle rapidly, the feed can usually be transferred to the leaf from a beaker. If, however, the particles settle very rapidly, it is virtually impossible to pour the slurry out of a beaker satisfactorily. In this case, the best method is to make use of an Erlenmeyer flask, preferably one made of plastic. The slurry is swirled in the flask until it is completely suspended and then abruptly inverted over the leaf. This technique will ensure that all of the sohds are transferred to the leaf. 

The process for the transfer of analytical methodology is, on the surface, a relatively simple operation. In its most common form, analytical method transfer is the verification that a method or test procedure works in an equivalent fashion at two or more different sites or laboratories and meets all acceptance criteria. This process is driven by compliance and governed by a statistical treatment of the resulting data. This interlaboratory transfer aspect of the overall transfer process has been covered comprehensively by McGonigle, who stressed that successful transfers are linked to the method validation process. Method transfer was defined in this case as the introduction of a validated method into a designated laboratory so that it can be used in the same capacity for which it was originally developed. The second portion of the technology transfer... 

Method transfer is loosely defined as a process that qualifies a laboratory to use a test procedure or analytical method. According to this definition, any and all means of having a laboratory qualified would meet the criteria for transfer. The most common variations of method transfer are comparative testing, covalidation between two laboratories or sites, complete or partial method validation or revalidation, and the omission of formal transfer processes, sometimes termed the transfer waiver. ... 

Under the procedure of BAM certification of plastic geomembranes for landfill liners, special test methods and requirements have been specified for geomembranes with textured surface. Table A 1.4 in Appendix 1 shows the test procedures and requirements from the certification guidelines (Muller 2001), which aim to secure service lifetimes comparable to that of a smooth geomembrane. To what extent the requirements may be reduced if a shear stress transfer is required for only small or normal service lifetimes (see Table 5.1), is difficult to assess. 

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. 

The process for the transfer of analytical methodology is, on the surface, a relatively simple operation. In its most common form, analytical method transfer is the verification that a method or test procedure works in an equivalent fashion... 

A variety of experimental paradigms are available and used in animal studies, and it is clear that some of these, such as those assessing learning, concept formation, or retention, are readily transferable to studies of children. Yet this has not been done. It is possible that this is simply due to a lack of familiarity with the techniques and details of animal work on the part of researchers with children. It may also demonstrate a lack of confidence to move away from the traditional and well-used techniques and tests, and to implement new methods and procedures. 

Standard reference materials provide a necessary but insufficient means for achieving accuracy and measurement compatibiUty on a national or international scale. Good test methods, good laboratory practices, well-qualified personnel, and proper intralaboratory and intedaboratory quaUty assurance procedures ate equally important. A systems approach to measurement compatibiUty is ikustrated in Figure 2. The function of each level is to transfer accuracy to the level below and to help provide traceabiUty to the level above. Thus traversing the hierarchy from bottom to top increases accuracy at the expense of measurement efficiency. 

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