Quality by Design: A Contract Organization's Perspective

The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes. This article is part of a special issue on outsourcing.
Jul 31, 2012

Quality by design (QbD) is based on sound science and quality risk management through which quality is built into products. Although the benefits of QbD are obvious, the industry has been relatively slow in adopting the concept because QbD often falls low on the list of immediate priorities. With product development and manufacturing increasingly being outsourced to contract development and manufacturing organizations (CDMOs), however, a strategic partnership between the sponsor and a CDMO can help realize the benefits of QbD. The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.

Whether the product and process is developed at one contractor's site, transferred from one contract developer to another, or transferred from a sponsor development unit to a contract development and manufacturing organization (CDMO), knowledge transfer, an in-depth process understanding, identification of critical process parameters, and determination of proven acceptable process ranges (PAR) are crucial to successful development. By failing to identify and correct the root causes of problems early in the design phase of the process- and product-development cycle, organizations risk quality, yield, and supply-chain issues. Quality by design (QbD) should be viewed as an opportunity that brings value and business benefits to both the sponsor and the CDMO.

QbD benefits offered by a CDMO

A CDMO supports the development of hundreds of molecular entities in different stages of clinical programs with small or large molecules in sterile and nonsterile processes. A wealth of knowledge and experience resides with a CDMO that could be leveraged by a sponsor for new projects. Drawing on knowledge gained from experience, a CDMO can move quickly in identifying critical steps, building a robust model to plan, and designing experiments to address problems. We often find that when sponsors have changed hands due to licensing of new chemical entities, some information and documentation does not get transferred. A CDMO can help the sponsor orle001anize information, determine gaps, and work to build the program to meet the quality and regulatory requirements. QbD requires a solid base of knowledge of the drug substance, its physicochemical properties, characterization, raw material and excipient interactions and variability, and how all these impact the dosage form design, target product profile, and shelf-life stability. A CDMO can leverage its inventory of knowledge and experience, work with a sponsor to lay out a plan, and apply the principles of ICH Q8, Q9, and Q10 to develop a QbD strategy that adds value to the sponsor's program (1–3).