YHU Scientific Journal, Vol 9, p. 24-32, 2023
IMPURITIES IN NEW DRUG SUBSTANCES AND DRUG PRODUCTS AS A PART OF THEIR REGULATION PROCESS
V. M. Ghazoyan, El T. Kh. M. Kenawy
Submitted, 23.05.23, accepted 24.07.2023
Abstract։ : Any drug substance or drug product can exist in the market only after its registration process. During the registration, quality of the substance/product should be ensured. For that reason, there is the need for very clear understanding whether any impurities and/or degradation products can be raised during its manufacturing process and/or shelf life. In the case if they can occur, proper analytic procedures should be described and followed in order to understand which impact can have these compounds on the quality, safety and efficacy of the drug substance/product. This work extracts all parts of CTD where information about impurities should be provided align with ICH reference guidelines and main principles, which should be followed. Additionally, there were compared the main characteristics of the registration processes of drug substances and drug products.
Keywords: : drug substance, registration process, degradation, safety and efficacy of the drug