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

ABSTRACT

Introduction: 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.

KEYWORDS:

• Quality by design
• product design
• process design
• risk management
• nanocarrier
• drug delivery system

Article highlights

• Conceptual understanding of QbD is based on Product design goal, Process design space, Control space and Operating space.

• QbD, a regulatory-driven approach emphasizes on product as well as process control for systematic product development based on predefined goals and quality risk management.

• QbD concept is gaining popularity among manufacturing industries and regulatory bodies.

• Safety and efficacy of various drug delivery systems can be ensured by the optimal use of QbD.

• QbD tools facilitate a higher level of process understanding, root cause investigation and developing control strategies in the process and formulation development.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties

Reviewer Declaration of Interest

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose

Additional information

Funding

This paper was not funded