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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Making the effort to apply new methods to pharmaceutical processing will bring benefits.
At the INTERPHEX show last month in New York City, several conference sessions focused on quality by design (QbD). One of these was a panel discussion sponsored by Pharmaceutical Technology, “Lessons Learned: Successes and Challenges in Implementing Quality by Design.” Panelists agreed that QbD approaches have proven to offer benefits to industry, although it was clear that there is more work to be done in implementing QbD.
Panelist Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck, noted that a benefit of QbD is increased process understanding, which results in higher quality at a lower cost. He emphasized that QbD encompasses both customer needs and business requirements, because a science- and risk-based approach results in a high level of assurance that patient needs will be met.
A second panel member, Dr. Chris Moreton, partner at FinnBrit Consulting, discussed how QbD methods can be used to incorporate excipient variability into a design of experiments. He explained that samples at the extremes of specification are most often not available and that there are other ways to attain the necessary understanding.
Panelist Jonathon Thompson, senior manager of Compliance Services Consulting at Invensys Operations Management, discussed using process analytical technology (PAT) and inferential sensing (i.e., simple measures, such as pressure and temperature, correlated to parameters) to obtain real-time data. He also discussed using advanced process control (APC) of manufacturing processes. APC is a dynamic optimization of the process either via an open loop (i.e., engineers make a decision to adjust the process) or closed loop (i.e., the control system automatically makes changes directly to the process). Dynamic optimization is a cultural change, noted Thompson, but has the potential to improve reliability and consistency and to reduce release time.
Real-time release (RTR) is ready to be implemented and is, in fact, already being used, agreed the panelists. Challenges for RTR include controlling risk (a factor to which regulators are particularly attuned) and managing analysis failures. Parallel testing early in manufacture can be used to verify RTR.
Going forward, Lepore noted a need for improved global harmonization of regulatory expectations. Actions toward more consistent interpretation and application of International Conference for Harmonization (ICH) guidelines and greater collaboration involving industry and regulators would form important first steps. He also suggested that industry members need to share more real examples to continue to drive alignment and understanding.
Other conference sessions at INTERPHEX did present examples of using QbD. Dr. Carl Anderson from Duquesne University, for example, presented an example of how cycle time was significantly improved using PAT. Richard Creekmore from AstraZeneca discussed improving process robustness and gave examples of risk assessments.
Examples of applying QbD were also the focus of a recent webcast, "A Pragmatic Application of QbD: Turning Theory into Tangible Success," moderated by Pharmaceutical Technology earlier this month with experts from Patheon. The complimentary, on-demand webcast can be accessed here.