Implementation of a fully integrated CM direct compression and coating process at a commercial pharmaceutical facility – Part 2: PAT and RTD results for normal operational conditions batches

Author:

Rosas Juan G.,Brush Peter,Thompson Bruce,Miller Charles,Overton Paul,Tugby Neil,Stoliarskaia Daria,Hurley Samantha,Ramasamy Manoharan,Conway Stephen L.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference41 articles.

1. Control Strategies for Drug Product Continuous Direct Compression—State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products;Almaya;J. Pharm. Sci.,2017

2. ASTM, 2017. ASTM E1655-17 Standard Practices for Infrared Multivariate Quantitative Analysis.

3. ASTM, 2021. ASTM D6122-21. Standard Practice for Validation of the Performance of Multivariate Online, At-Line, Field and Laboratory Infrared Spectrophotometer, and Raman Spectrometer Based Analyzer Systems.

4. Why We Need Continuous Pharmaceutical Manufacturing and How to Make It Happen;Badman;J. Pharm. Sci.,2019

5. Effective Sample Size in Diffuse Reflectance Near-IR Spectrometry;Berntsson;Anal. Chem.,1999

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