STEPHEN CLOSS  
Patheon, 111 Consumers Drive, Whitby, Ontario, L1M2M1, Canada

Abstract

An effective Quality by Design program executed with a Contract Organization is based on open communication to ensure complete knowledge transfer and risk assessment. Evaluating and addressing gaps early in the product lifecycle can ensure robust processes are developed leading to successful commercialization of a dosage form meeting quality target product profile requirements. Sponsor concerns over cost, timeline, and sharing of proprietary information can sometimes derail the Quality by Design process, leading to delays and unnecessary repetition of experimentation late in the development process. Current regulatory environment not only encourages but mandates complete information sharing between contractor and sponsor to facilitate the development and commercialization of quality products using sound QbD principles.

Quality by Design (QbD) is based on sound scientific principles and quality risk management to ensure that the aspects of quality are incorporated into the design of the process and that the process consistently meets safety and efficacy targets. Even though the benefits of QbD are obvious, a Contract Development and Manufacturing Organization (CDMO) in the pharma industry often faces challenges in executing QbD programs due to the sponsor’s pre-determined expectations of product development requirements in terms of scope and key milestones/timelines. A contract manufacturing organization must maximize efficiency during transfer and process development to gain the knowledge necessary to design quality manufacturing processes and still meet timelines and budget.

Often times the sponsor focus is on determining a set of target operating conditions that meet initial primary quality targets, so as to quickly progress to clinical trial manufacturing and product commercialization. What is initially believed by the sponsor to be a cost effective and streamlined approach to product development can result in redundant or ineffective studies. Characterization trials must be repea ...