Articulation of Quality By Design Elements for Product Development and its Unique Applications

摘要

Quality by Design (QbD) is a methodical approach to pharmaceutical product development that begins with predefined objectives and emphasizes product and process comprehension and process control based on sound science and quality risk management. Pharmaceutical development should lead to the design a quality product and its manufacturing process to meet the QTPP and CQA parameters. To arrive at the robust product development QbD articulation is important which is missing in most of the reviews. This review articulates the QbD elements in the product development. QbD process stars with identification of QTPP and source CQA from QTPP. CMAs and CPPs are derived with risk assessment from the product ingredients and process. Their impact on the CQAs can be studies with DoE tools. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the design space and control strategy. Product process follows life cycle management approach with continuous improvement. PAT tools are utilized for the online monitoring of the processes. This review paper is dedicated to provide QbD element articulation in product development and its unique applications in the various areas of the product development such as Biotechnology, Nanotechnology products, Nasal products, Inhalation, Injectable products, Targeted drug delivery, complex Solid oral, Transdermal and topical products, Bioavailability and dissolution enhancement, Analytical processes and API manufacturing etc. Current trends in the technical application of the PAT tools are discussed.