Process Development

Aug 02, 2017
Pharmaceutical Technology
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
Aug 02, 2017
Pharmaceutical Technology
Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
Jul 02, 2017
Pharmaceutical Technology
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
Jul 02, 2017
Pharmaceutical Technology
Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.
Apr 01, 2017
Pharmaceutical Technology
Process analytical technology, based on monitoring particle size distribution and tracking coating thickness measurements in real time, can be used to predict the dissolution of polymer-coated multiparticulates.
Feb 15, 2017
Equipment and Processing Report
Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.
Feb 14, 2017
Equipment and Processing Report
Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.
Jan 09, 2017
By Pharmaceutical Technology Editors
GEA’s ConsiGma continuous tableting line combined with Siemens’ automation and Sipat data management systems enables continuous manufacturing.
Jan 02, 2017
Pharmaceutical Technology
As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.
Dec 05, 2016
By Pharmaceutical Technology Editors
FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.
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