FDA and EU Regulatory Approvals for Transmission Raman Spectroscopy (TRS) Based Methods – a Replacement of Few Heavy Load LC Methods

Transmission Raman spectroscopy (TRS) is an evolving technology offering an alternative to conventional analytical testing, mainly chromatographic for finished products as well as in-process assay and content uniformity controls. 

TRS takes seconds per tablet or capsule analysis, does not require sample preparation, and works with a wide variety of finished products. TRS model development and validation require chemometrics expertise. In addition, specially designed batches (API and excipients content) have to be manufactured for ensuring the method is fitted for its purpose and its robustness.

TEVA has successfully initiated several TRS developments and succeeded to implement TRS methods in a quality-controlled environment, receiving several regulatory offices’ approvals. 

The complexities faced during the development and validation of methods, scientific and managerial ones, as well as the TRS global platform developed within Teva will be discussed in this presentation