All Categories (1-3 of 3)

1. Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description

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   09 Jun 2023 | Contributor(s):: Popkin, ME, Omer, BASeibert, KD, Luciani, CV, Srivastava, S, Hobson, L, Lepore, JV

   A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API...

2. A Review of Process Analytical Technology (PAT) in the U.S. Pharmaceutical Industry

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   09 Jun 2023 | Contributor(s):: Munson, James, Stanfield, C. Freeman, Gujral, Bir

   Process Analytical Technologies (PAT) are used to provide timely analysis of critical quality parameters with the end goal of improving final product quality as well as reducing manufacturing costs, thereby significantly benefiting the Pharmaceutical Industry. PAT involves mostly on-line or...

3. A flowsheet model for the development of a continuous process for pharmaceutical tablets: An industrial perspective

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   09 Jun 2023 | Contributor(s):: Garcia-Munoz, Salvador, Butterbaugh, Adam Leavesley, Ian Manley, Leo Francis, Slade, David, Bermingham, Sean

   A dynamic model of a continuous direct compression process for pharmaceutical tablets is presented. The objective is to assess the impact of the variability from the feeder system on the concentration of drug in the powder in the feed frame of a tablet press. The model is based on principles of...