Analytical method transfer issues

The old adage if it isn t written, it isn t done certainly applies to analytical transfer. The expectation of the health authorities is that a final report will be issued documenting the analytical method transfer process and associated results. Two types of records are subject to PAI Primary records that demonstrate safety, purity, and efficacy of the drug (e.g., batch records, test data) and supporting documentation such as equipment verification records, change control and development and validation reports that demonstrate the cGMP compliance status of the facility. The method transfer report is categorized vmder the latter set of documentation. 

Eventually the point will be reached at which the development of a product is complete the formulation is finalized, the equipment has been selected, the analytical methods are validated, the development transfer report has been issued, and the Preapproval Inspection (PAI) is anticipated. Now is the time to consider validation of both the manufacturing and cleaning processes. Although some process validation may have also been completed or a process validation protocol may have been prepared and approved, it is likely that very little has been finished that would enable us to state that the cleaning process is fully validated. 

The designated laboratory is responsible for issuing and following SOPs that define their criteria for accepting an analytical method. The method transfer report includes data generated in accordance with those SOPs. 

The primary hindrance to the universal implementation of UHPLC is, for most laboratories, that the platform often requires new capital outlays to buy instrumentation capable of running at higher system pressures (typically above 400-1,500 bar). Access to properly qualified systems can create a roadblock to routine regulated testing. This limited availability of UHPLC becomes less of an issue each year as instrumentation comes to an end of its depreciation lifespan and gets replaced with newer LC systems. Yet, in the current state, pharmaceutical companies across the industry are less inclined to develop and transfer UHPLC analytical methods until they are convinced receiving laboratories have qualified UHPLC systems available on demand. In addition, not all UHPLC instruments perform to the same specifications (14), making transfer even more difficult as vendor-specific limitations can potentially cripple an analytical transfer. 

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