process validation to ensure consistency and quality of the final product is key when reaching the later stages of development prior to commercialization. During the development stages we will work to assess an appropriate scale for clinical manufacturing and make recommendations on process development strategies. INADEQUATE PACKAGING AND STORAGE CONDITIONS CAN CAUSE INSTABILITY AND DEGRADATION OF THE API. Failure to think about the packaging suitability can lead to overprocessing during clinical trials as well as poor patient compliance. Selecting appropriate packaging that takes into consideration the end patient population, trial logistics and the commercial product goal is key. Appropriate selection of storage conditions via adequate stability data ensures robustness of the API increasing the longevity of clinical supplies.
compatibility, forced degradation studies and accelerated stability testing. At SGS Quay Pharma, our work is supported by access to the latest technologies, and all prototype formulations are subject to in-depth screening and stability evaluation in a non-GMP environment. LACK OF REGULATORY COMPLIANCE CAN RESULT IN DELAYS OR REJECTION OF THE FORMULATION DURING THE APPROVAL PROCESS. Ensuring regulatory compliance by following current good manufacturing practices (cGMPs) and consulting with regulatory authorities as needed is key to delivering safe and effective products to patients. FAILURE TO CONSIDER MANUFACTURE PROCESSING & SCALE-UP ASPECTS CAN LEAD TO VARIATIONS IN THE FINAL PRODUCT AND POTENTIAL SAFETY RISKS. Using a Quality by Design (QbD) approach during the development stages minimizes risk, improves quality and looks to increase efficiency while in the product development phase. With advanced facilities and in-house analytics, we provide a framework to enable effortless scaling-up of products for clinical manufacturing beyond phase I. Performing robust
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