![]() ![]() ![]() Additional lots may be tested if desired. Note: A single lot is required because this analysis is not of the manufacturing process, but rather of the method’s performance. A single lot of the article (product, API, device, system) is required for testing.All staff at the receiving laboratory shall be properly trained and qualified to run analytical methods.The receiving laboratory shall run through procedure(s), methods, document(s) received and identify any issues prior to the start of the execution of the transfer protocol.The transferring laboratory shall provide necessary training to the receiving laboratory for all non-USP tests.Reference/test standards, methods, and samples shipped from transferring laboratory to receiving laboratory – Validation report(s), and any/all additional required documents to the receiving laboratory.The receiving laboratory shall verify that all equipment is qualified and properly calibrated – laboratory equipment/system(s) are in compliance with all applicable regulations and user specifications.The receiving laboratory shall verify that all equipment/system(s) required to perform the method testing is available.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. The method is transferred without comparison data or generation of inter-laboratory data and the receiving laboratory is considered qualified for the transferred method. A Transfer Waiver is an appropriate, justified omission of a transfer process. In lieu of the above types of transfers, a facility may choose to pursue a Transfer Waiver. Revalidation/Partial Revalidation – Complete or partial method validation per Validation of Compendial Procedures by the receiving laboratory.An assessment is conducted, using a transfer protocol, to evaluate the reproducibility of the process. Co-validation of Laboratories – The transferring laboratory works with the receiving laboratory in an inter-laboratory validation effort at the transfer laboratory site.The acceptance criteria and the acceptable variability are outlined in a transfer protocol. Comparative Testing – Analysis conducted on samples, from the same lot of product/API/device/etc., by both laboratories and acceptance criteria is met.The analytical methods are required for subsequent formulation and process development. In ProPharma’s 9 Gate Tech Transfer Methodology, analytical method transfer is completed and verified in Gate 5. 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 other words, the method may have been developed by a manufacturing facility (internal) and be sent to an external (contracted) laboratory for testing. As mentioned above, the two laboratories can be external or internal to one another. These two types of laboratories can have varying relationships. 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. 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.Ĭontact Us But First, a Little Background… ![]()
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