![]() ![]() They also ensure final material quality, from content to uniformity. Results of in-process tests are used to inform critical decisions made by formulators, and thus require accurate and timely results to facilitate efficient formulation development and production. It requires the thorough characterization of pharmaceutical products and the processes by which they are developed and produced. ![]() ![]() This is underscored by the FDA’s Quality by Design (QbD) initiative, in which product and process understanding is applied to preemptively control variation and reduce risk. In this post we explore how leading pharmaceutical companies are using assay by potentiometric titration to control variation and reduce risk during the drug manufacturing processes.Īnalysis of composition and quality is essential at every stage of the pharmaceutical manufacturing process, from formulation development to production. Welcome to the second of six articles in our analysis and compliance in pharmaceuticals series. ![]()
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