TY - THES ID - 135198350 TI - Qualification and Comparability Protocols for Reference Standard and Starting Materials - Implementation and optimization of templates and strategy within GSK AU - Geens, Thomas AU - Declerck, Paul AU - KU Leuven. Faculteit Farmaceutische Wetenschappen. Opleiding Master in de geneesmiddelenontwikkeling (nieuw programma vanaf 2017-2018) (Leuven) PY - 2020 PB - Leuven KU Leuven. Faculteit Farmaceutische Wetenschappen DB - UniCat UR - https://www.unicat.be/uniCat?func=search&query=sysid:135198350 AB - The implementation of international guidelines on qualification/comparability protocols has the potential to benefit the company and regulators by reducing the review time and the number of submissions needed for specific cases of periodic and predictable changes. The study aimed to establish an overview of recently submitted qualification/comparability protocols for reference standard and starting material, and developing a strategy within GlaxoSmithKline (GSK), to enable the update or construction of regulatory affairs Chemistry, Manufacturing and Controls (CMC) templates for these protocols. This strategy and the templates will be implemented for all future GSK submissions for these changes. Information on recently submitted protocols was collected by a general and a company internal literature study. Recent submission packages from different GSK vaccines were identified and studied for their content and structure. Information on the strategy of the company was gathered and established by the Global Regulatory Affairs (GRA) Regional Team. The gathered information enabled the implementation and optimization of a clear structure to show the required qualification/comparability protocol with the content necessary to be aligned with regulatory guidelines. The strategy of the company focuses on gaining acceptance of an EU-like model in other countries or regions by local advocacy. Countries and regions are classified into A-and B-countries to determine further submissions and advocacy efforts. ER -