Abstract

“QbD Driven Technology Transfer: An Overview of Some of the Elements, Nuances and Challenges in the Industry”

Shib Mookherjea, Senior Director, ValQual International

Technology Transfer plays a very important role in Pharmaceutical Development across the industry and sometimes can have impact on the upscaling and eventually commercialization. . Often this could be the preferred pathway, comprising of steps, procedure and interdepartmental interactions, participations that need to be properly contemplated and coordinated to be execute properly. Information, knowledge, findings, data from early stages of Development need to be passed on , shared with between donor and recipient groups with a QRM strategy ensuring all the intricacies of Data Integrity within the organization . This brief presentation will aim at providing an overview of the process of Tech Transfer (as commonly referred to) while identifying some of the critical elements, intricacie, factors in cross functional relationships and responsibilities. Examples of support from Analytical Development teams and interactions with QC or Global Tech Operations (GTOPs), with respect to spec setting for certain Dosage forms , Methods validation, Methods  Transfer etc. will be touched upon and discussed , while also mentioning the guidelines from international organizations.