Transfer of method

Reproducible and consistent performance (direct transfer of methods between API systems without re-optimisation)... 

The author has not tried to include a complete ab-initio literature search in any particular area. The majority of references in the text are from recent publications (1980-2003). This is not because excellent older references are no longer relevant. Rather, these are frequently no longer used because (i) more recent work is a fine-tuned extension of prior work (ii) the classic texts list extensive work up to 1980 and (iii) older methods are frequently based on inferior or obsolete technology and thus direct transfer of methods may be difficult or impossible. Readers familiar with the classics in the field will find that almost everything has changed considerably. 

Reproducibility. Reproducibility expresses the precision between laboratories and would usually involve technical transfer of methods to laboratories in different geographical locations. The recommended testing for content uniformity, assays, degradation and impurity methods, and dissolution methods are listed in Table 5.2. 

One should verify that the method of recordkeeping in the development laboratory follows what is stipulated in the FDA s Laboratory Inspection Guide, from June 1992. The system should also be evaluated for the transfer of validated analytical methods. On-site validation of the method is required for analytical methods validated at another laboratory. A written procedure should be available covering both the transfer of methods and on-site validation... 

All phases of analytical development are ideally supported by chemical separation techniques such as HPLC, TLC, GC, SFC, and CE. HPLC continues to be the primary method of analysis throughout the pharmaceutical development process. Although HPLC is limited in its ability to separate more than 15-20 components in a single analysis, and variations in columns and instrumentation manufacturer to manufacturer complicate transfer of methods, HPLC can readily be implemented to meet ICH requirements for method performance. For early-phase methods, HPLC can be coupled dynamically to mass and nuclear magnetic resonance spectrometers to facilitate the identification of unknown impurities. In later phases, HPLC can be implemented in a fully automated format as a high-throughput method for release and stability testing. 

Conclusions on the Transfer of Methods from HPLC to UHPLC... 

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