USP 39 – Transfer of Analytical Procedures – Free PDF Download

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THE ANALYTICAL PROCEDURE

The procedure should be written with sufficient detail and explicit instructions, so that a trained analyst can perform it with-out difficulty. A pretransfer meeting between the transferring and receiving units is helpful to clarify any issues and answer anyquestions regarding the transfer process. If complete or partial validation data exist, they should be available to the receivingunit, along with any technical details required to perform the test in question. In some cases it may be useful for the individu-als who were involved with the initial development or validation to be on site during the transfer. The number of replicatesand injection sequences in the case of liquid or gas chromatography should be clearly expressed, and, in the case of dissolu-tion testing, the number of individual dosage units should be stipulated.

TRANSFER REPORT

When the TAP is successfully completed, the receiving unit should prepare a transfer report that describes the results ob-tained in relation to the acceptance criteria, along with conclusions that confirm that the receiving unit is now qualified to runthe procedure. Any deviations should be thoroughly documented and justified. If the acceptance criteria are met, the TAP issuccessful and the receiving unit is qualified to run the procedure. Otherwise, the procedure cannot be considered transferreduntil effective remedial steps are adopted in order to meet the acceptance criteria. An investigation may provide guidanceabout the nature and extent of the remedial steps, which may vary from further training and clarification to more complexapproaches, depending on the particular procedure

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Manostaxx – Industrial Management Consulting

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