Should Fda Promote More Process Analytical Technology And...

Should FDA promote more Process Analytical Technology and Quality by Design approaches for more successful impact on manufacturers’ ability to maintain consistent quality? The Process analytical technology (PAT) and Quality by design (QbD) approaches are used to create quality in a product. Each approach offers manufacturers the framework to create consistent quality and potential to increase efficiency in the production of a drug product. The two approaches offer some key issues: increased product knowledge and understanding but critical to identify the correct quality attribute; offer flexibility in the post-approval of a product but the acceptance of concept can be challenging; and can create a more efficient process but very expensive†¦show more content†¦The QTTP identifies critical quality attributes (CQAs), which establish a limit or range to ensure a desired process quality. The QTTP also identifies the critical process parameters (CPPs), which are used to monitor or control a process to ensure the process produce the desired quality on a CQA. The QbD works within the design space to achieve a process that performs consistent to CQAs and CPPs affect on overall quality. A control strategy is used to ensure quality in the product is maintained throughout the process and all phases of the product lifecycle. QbD can be used throughout the entire lifecycle to improve efficiency and quality of the product. The process analytical technology approach involves process understanding combined with monitoring in-process product attributes in real time by adjusting process parameters to build quality in a product. The PAT approach combines process understanding, principles and tools, and strategy for implementation. Principal understandings consist of understanding the variability of critical sources, managing the process variables, and product quality is accurately predicted through the design space. The PAT principles and tools help companies understand the physical, chemical, and biological attributes, which provides information for process understanding. The knowledge acquired from implementing process understanding and principles and tools are used to develop a strategy for implementation. Why