Okita’s and Hussain’s presentations bookended customer presentations and discussions that are an integral part of the annual DISCOVER conference. A wide range of life sciences companies shared their experiences, perspectives and best practices in implementing a QbD program not only internally but across their virtual manufacturing networks that include contract manufacturing organizations (CMOs). These companies have implemented a Process Intelligence software platform that provides on-demand, self-service data access for all types of process and quality data, including paper-based data. This specialized software provides automated data contextualization for observational and investigational analytics and reporting.
One company highlighted how it designed one of its new plants as a paperless manufacturing facility with the business goals of reducing deviations, expediting batch review and release, improving data analytics capabilities, improving inventory management and driving standardization. The challenge was to create context around the data and organize the data from separate source systems. By implementing the Process Intelligence platform the facility was able to create a process hierarchy which aggregates data from multiple electronic systems (e.g., LIMS, MES) and contextualizes data automatically for analysis and trending. The process hierarchy now supports the company’s annual product reviews (APRs), quality investigations, process improvements, statistical process monitoring and tech transfer.
Another manufacturer presented shared experiences with implementing the Process Intelligence platform to support its PAT initiative for solid dosage form production. Aegis’ experts reviewed scenarios for situations, such as IT and Quality departments using shared process data for collaboration during root cause investigation of problems.
The DISCOVER conference presentations and discussions proved that QbD continues to evolve from a theory to a practice as testing, planning and implementation within organizations continue and the business benefits become more compelling. Shared process understanding throughout all areas of process development, tech transfer, manufacturing and quality is happening today and contributing to adequate product supply, process efficiencies, reduced costs and continuous improvements – with lessons to learn from leading manufacturers who agree that quality is a necessity – not an option.
About the Author:
Justin O. Neway, PhD, is executive vice-president, chief science officer, and cofounder of Aegis Analytical, 1380 Forest Park Circle, Suite 200, Lafayette, CO 80026, tel. 303.625.2100, firstname.lastname@example.org.
1 July 27, 2011 Meeting of FDA Advisory Committee for Pharmaceutical Science, Presentation on QbD Implementation “State of QbD Implementation: Adoption, Success and Challenges,” Ted Fuhr, McKinsey & Company.