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Method transfer, is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (the transferring unit), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferring analytical procedure as intended. Transfer unit/lab is the site, which develops & validates the analytical methods and subsequently transfers to the user lab (receiving lab) for analysis of routine finished product or API batches.
Types of Transfers
Comparative testing : Comparative testing requires the analysis of a predetermined number of samples of the same lot by both the sending and receiving unit. Comparative study will be performed based on preapproved transfer protocol that stipulates the details of the test procedure, the samples that will be used and the acceptance criteria.
Covalidation Between Two or More Laboratories : The laboratory that performs the validation of the analytical procedure is qualified to run the procedure. The transferring unit can involve the receiving unit in an interlaboratory covalidation including them as a part of the validation team at the transferring unit and thereby obtaining data for the assessment of reproducibility (Reproducibility expresses the precision between laboratories at different days, different analysts, different equipment with sample from same batch/ lot etc.). Covalidation study will be performed based on preapproved validation protocol that stipulates the details of the test procedure, the samples that will be used and the acceptance criteria.
Revalidation :Revalidation or partial revalidation is another approach for transfer of a validated test procedure. The following validation characteristics regarded as the most important for the partial revalidation of different types of analytical procedures.
• System suitability
• Specificity
• Linearity
• Limit of Detection
• Limit of Quantitation
• Precision
• Accuracy
