Integrating Quality By Design (QbD) In Medical Device Manufacturing

By Stevens Institute of Technology

The medical devices industry, as well as the pharmaceutical industry, is slowly but indisputably accepting the concept of Quality by Design into its design and development product phases, and is introducing the statistical tools and methods of the concept into its process verification and validation phases as well. The Quality by Design concept or approach has found its implementation in the medical devices life cycle management, under the guidance of risk regulations by the International Conference on Harmonization. Since the importance of successful implementation of this concept is ever more evident in industry, this white paper will therefore discuss the concept and its possible implementation in the medical devices industry, along with the benefits and concerns expressed by the manufacturers.

Quality by Design (QbD) is a relatively new concept in the pharmaceutical industry and is therefore questioned by many as to whether the costs associated with its implementation and the benefits as a result of the implementation of the concept are worth the effort. Some smaller companies describe the concept as the latest ‘flavor of the month' from the FDA, hoping to stay the course with the traditional way of product manufacturing and control. At the same, many of the larger pharmaceutical companies, which comprise at the forefront the medical devices companies, have taken on the QbD challenge and its statistical tools as an opportunity to improve their manufacturing processes early on in the design phase. This white paper will introduce the concept of Quality by Design and its integration into the medical devices industry, along with its challenges and benefits.

As a relatively new concept, the Quality by Design (QbD) was first introduced into the Chemical Manufacturing Control (CMC) review process in 2004 as a result of the FDA's new 21^st century cGMP initiative. The QbD concepts, together with the Process Analytical Technology (PAT), are the cornerstone of a bold new initiative by the FDA to initiate a new system that will incorporate more quality and understanding of the manufacturing process by industry. Quality by Design carries with it a more broader understanding of processes involved in medical devices manufacturing by determining the impact of critical process parameters (CPP's) on the actual critical quality attributes (CQA's). This involves clearly understanding the manufacturing and product process capability, and controlling this capability within its pre-determined limits. The safety and quality of the product is of paramount importance during implementation of QbD, and whenever there is process control, clear existence of risk is anticipated.