383038 In-Process Particle Size Analysis for Commercial Pharmaceutical Manufacturing

Wednesday, November 19, 2014: 3:15 PM
203 (Hilton Atlanta)
Zhigang Sun, Division of Product Quality Research, CDER, FDA, Silver Spring, MD

Particle sizes of drug substances, excipients, and intermediates are of great importance for most of solid oral dosage forms and are traditionally monitored and controlled by laboratory (off-line) analysis. Owing to advances in particle sizing techniques as well as implementation of process analytical technology (PAT) and quality by design (QbD), in-process particle size analyzers have been used in a variety of pharmaceutical applications recently. In-line or on-line particle size analysis has been demonstrated to be a useful tool to provide continuous real-time information, enhance product and process understanding, and ensure final drug product quality. However most of these applications focus on product and process development stages and little information is available on how to implement in-process particle size analysis for large-scale commercial manufacturing processes.  The objective of this presentation is to discuss the current state of art regarding use of in-process particle size analysis for routine commercial manufacturing processes as well as its benefits and challenges.  Some regulatory considerations with regard to submission and evaluation of in-process particle size analysis at commercial pharmaceutical manufacturing processes will also be discussed in this presentation.

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