Quality by design (QbD) approaches in current pharmaceutical set-up

Abstract

Quality by design (QbD) encourages the pharmaceutical industry to use risk management and science-based manufacturing principles to gain process and product understanding and thus assures quality of the product. With the objective to curb the rising costs for development and regulatory barriers to innovation and creativity, QbD is being widely promoted by Food and Drug Administration (FDA) and International Conference on Harmonization (ICH). Areas covered: This review describes the elements, different design and tools of QbD as well as multidimensional applications of QbD ranging from dosage form and method development to meeting latest regulatory requirements. Expert opinion: The understanding of a process is facilitated by proper identification of sources of variation, management of variability by process design, and prediction of product quality attributes using design space. The pharmaceutical industry is rapidly adopting the QbD principles for fabrication of safe, effective and quality products; however, we are still on a journey and the process of gathering all experience and metrics required for connecting and demonstrating QbD benefits to all stakeholders is still in progress. Understanding the formulation and process parameters with the philosophy of QbD will be useful for the optimization of complex drug delivery systems in the near future.

Pharmaceutical Development of Liposomes Using the QbD Approach

“…In order to study the relationship between the CMAs and CPPs and their impact on CQAs in a mathematical form, the Design of Experiments (DoE) strategy is used. This method also allows to establish the design space by running a minimum number of experiments [2,11,19]. The design space for liposome preparation may be established by implementing the QbD strategy as a systematic approach in liposome development, in order to improve the product quality, by understanding and controlling formulation, materials, and manufacturing variables.…”

Quality by Design (QbD) Approach for Optimization and Characterization of Micro emulsion based Nasal formulation of Antipsychotic/Antischizophrenic Drug-Aripiprazole

“…Based on solubility, oleic acid is selected as oil phase while Tween 80 and Transcutol -p are selected as surfactants and co surfactants respectively for micro-emulsion formulation. [7][8][9] Pseudo ternary phase Figure 2: Response surface plot for particle size and drug content.…”

“…5 QBD is now an integral part of formulation development at lab as well as industrial level because factorial design gives best optimized batch for pilot plant scale up. 6,7 Present work is focused on QBD approach based development of effective intranasal drug delivery system for Aripiprazole in the form of micro emulsion.…”

Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch

“…According to the ICH, quality by design (QbD) is a systematic approach to the development of pharmaceuticals that is based on sound science and quality risk management, with an emphasis on predefined objectives, product and process understanding, and process control (15,16,(19)(20)(21)(22)(23)(24). In the language of QbD, predefined objectives are reflected in the definition of the quality target product profile (QTPP) with the goal of achieving the intended therapeutic outcome and in the identification of critical quality attributes (CQAs).…”