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The need for greater process understanding raises the bar for suppliers.
After attending several events during the past few months, including conference sessions at Informex in Charlotte, North Carolina, in February, and the educational programs during DCAT Week, the week-long event of the Drug, Chemical, and Associated Technologies Association' (DCAT) in New York City in March, I observed the growing importance of FDA's quality-by- design (QbD) initiative in the pharmaceutical supply chain.
Patricia Van Arnum
The QbD approach, which encourages a greater process understanding of a synthesis and related manufacturing for an active pharmaceutical ingredient (API), is not confined to the efforts of the large pharmaceutical companies. At the conferences that I attended, emerging pharmaceutical companies also spoke of the importance of QbD in a chemistry, manufacturing, and controls (CMC) package for APIs and finished drug products and of their interest in having a contract manufacturing organization (CMO) capable of developing a QbD-ready CMC process. Because many small pharmaceutical companies seek to partner with Big Pharma in their drug-development or commercialization efforts, making the CMC package acceptable to a potential large suitor, including incorporating QbD requirements, is important.
Large pharmaceutical companies also spoke of the need for CMOs and fine-chemical suppliers to share the process understanding in their manufacturing routes for the chemicals they supply, not just for finished APIs and advanced intermediates, but also for early-stage intermediates and starting materials. As the large pharmaceutical companies develop their regulatory filings with an QbD mindset, there is the growing expectation of suppliers to share deeper process information to facilitate those filings in a QbD-ready CMC environment.
Patricia Van Arnum is a senior editor of Pharmaceutical Technology.
» Read Patricia's blogs at blog.PharmTech.com.