As you plan for an upcoming Tech Transfer, have you considered if you are appropriately prepared to conduct an analytical method transfer? With the simple analytical method transfer checklist provided below, you will never have to wonder again.
Per the USP, the transfer of an analytical method is defined as the documented process that qualifies a laboratory (the receiving laboratory) to use an analytical method that originated in another laboratory (the transferring laboratory), whether that is internal or external to the receiving laboratory.
These two types of laboratories can have varying relationships. As mentioned above, the two laboratories can be external or internal to one another. In other words, the method may have been developed by a manufacturing facility (internal) and be sent to an external (contracted) laboratory for testing. Additionally, the method can be transferred from an internal laboratory to another internal laboratory of the same facility (i.e., a Product/Process Development laboratory to Quality Control laboratory).
In ProPharma’s 9 Gate Tech Transfer Methodology, analytical method transfer is completed and verified in Gate 5. The analytical methods are required for subsequent formulation and process development.
In lieu of the above types of transfers, a facility may choose to pursue a Transfer Waiver. A Transfer Waiver is an appropriate, justified omission of a transfer process. The method is transferred without comparison data or generation of inter-laboratory data and the receiving laboratory is considered qualified for the transferred method. This is based on risk analysis associated with the receiving laboratory’s experience and knowledge as well as the complexity of the product or method.
It is highly recommended that the method transfer process flow for each method is mapped. Once all the process flows are mapped, bottlenecks and areas of concern can be determined and mitigated. With a process in place and that process appropriately mapped, the analytical method transfer has every chance of success.
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