Good Laboratory Practices method transfer

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. 

This chapter reviewed a systematic approach to method development, validation of analytical methods, and successful transfer of the methods. Successful completion of each component is both a regulatory requirement and good laboratory practice. To ensure that the data are both accurate and reliable, qualified and trained laboratory analysts must perform methods on qualified equipment, using suitable standards. 

Analytical method transfer should be performed using a validated procedure this transfer data can be useful in determining intermediate precision of the method. The transferring laboratory should ensure that the recipient laboratory(s) is (are) current Good Manufacturing Practice (cGMP) compliant a record of successful audit by QA personnel is essential, especially if the laboratory is a contractor. 

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